191 results on '"van Delden OM"'
Search Results
2. Improved survival prediction and comparison of prognostic models for patients with hepatocellular carcinoma treated with sorafenib
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Labeur, TA, Berhane, S, Edeline, J, Blanc, JF, Bettinger, D, Meyer, T, van Vugt, Jeroen, ten Cate, DWG (David), de Man, Rob, Eskens, Ferry, Cucchetti, A, Bonnett, LJ, van Delden, OM, Takkenberg, RB, Johnson, PJ, Labeur, TA, Berhane, S, Edeline, J, Blanc, JF, Bettinger, D, Meyer, T, van Vugt, Jeroen, ten Cate, DWG (David), de Man, Rob, Eskens, Ferry, Cucchetti, A, Bonnett, LJ, van Delden, OM, Takkenberg, RB, and Johnson, PJ
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- 2020
3. Prevention of hepatic encephalopathy by administration of rifaximin and lactulose in patients with liver cirrhosis undergoing placement of a transjugular intrahepatic portosystemic shunt (TIPS): A multicentre randomised, double blind, placebo controlled trial (PEARL trial)
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de Wit, K, Schaapman, JJ, Nevens, F, Verbeek, J (Jos), Coenen, Sandra, Cuperus, FJC, de Kramer, M, Tjwa, ET, Mostafavi, N, Dijkgraaf, MG, van Delden, OM, Beuers, UHW, Coenraad, MJ, Takkenberg, RB, de Wit, K, Schaapman, JJ, Nevens, F, Verbeek, J (Jos), Coenen, Sandra, Cuperus, FJC, de Kramer, M, Tjwa, ET, Mostafavi, N, Dijkgraaf, MG, van Delden, OM, Beuers, UHW, Coenraad, MJ, and Takkenberg, RB
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- 2020
4. Adjuvant hepatic arterial infusion pump chemotherapy and resection versus resection alone in patients with low-risk resectable colorectal liver metastases - the multicenter randomized controlled PUMP trial
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Buisman, Florian, Homs, Marjolein, Grunhagen, DJ, Filipe, Wills Floris, Bennink, RJ, Besselink, MGH, Rinkes, I, Bruijnen, RCG, Cercek, A, D'Angelica, MI, van Delden, OM, Donswijk, ML, van Doorn, L, Doornebosch, PG, Emmering, Jasper, Erdmann, JI, IJzerman, Nikki, Grootscholten, C, Hagendoorn, J, Kemeny, NE, Kingham, TP, Klompenhouwer, EG, Kok, NFM, Koolen, S, Kuhlmann, KFD, Kuiper, MC, Lam, MGE, Mathijssen, Ron, Moelker, Adriaan, Oomen - de Hoop, Esther, Punt, CJA, Riele, WWT, Roodhart, JML, Swijnenburg, RJ, Prevoo, W, Tanis, PJ, Vermaas, M, Versleijen, MWJ, Veuger, FP, Weterman, MJ, Verhoef, Kees, Groot Koerkamp, B, Buisman, Florian, Homs, Marjolein, Grunhagen, DJ, Filipe, Wills Floris, Bennink, RJ, Besselink, MGH, Rinkes, I, Bruijnen, RCG, Cercek, A, D'Angelica, MI, van Delden, OM, Donswijk, ML, van Doorn, L, Doornebosch, PG, Emmering, Jasper, Erdmann, JI, IJzerman, Nikki, Grootscholten, C, Hagendoorn, J, Kemeny, NE, Kingham, TP, Klompenhouwer, EG, Kok, NFM, Koolen, S, Kuhlmann, KFD, Kuiper, MC, Lam, MGE, Mathijssen, Ron, Moelker, Adriaan, Oomen - de Hoop, Esther, Punt, CJA, Riele, WWT, Roodhart, JML, Swijnenburg, RJ, Prevoo, W, Tanis, PJ, Vermaas, M, Versleijen, MWJ, Veuger, FP, Weterman, MJ, Verhoef, Kees, and Groot Koerkamp, B
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- 2019
5. Safety and efficacy of transarterial embolization of hepatocellular adenomas
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van Rosmaleni, BV, Klompenhouwer, Julia, de Graeff, JJ, Haring, MPD, Meijer, VE, Rifai, L, Dokmak, S, Rawashdeh, A, Abu Hilal, M, Jong, MC, Dejong, CHC, Doukas, Michail, de Man, Rob, IJzermans, J.N.M., van Delden, OM, Verheij, J, van Gulikl, TM, van Rosmaleni, BV, Klompenhouwer, Julia, de Graeff, JJ, Haring, MPD, Meijer, VE, Rifai, L, Dokmak, S, Rawashdeh, A, Abu Hilal, M, Jong, MC, Dejong, CHC, Doukas, Michail, de Man, Rob, IJzermans, J.N.M., van Delden, OM, Verheij, J, and van Gulikl, TM
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- 2019
6. Colorectal liver metastases:Surgery versus thermal ablation (COLLISION) - a phase III single-blind prospective randomized controlled trial
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Puijk, RS, Ruarus, AH, Vroomen, LGPH, van Tilborg, AA, Scheffer, HJ, Nielsen, K, Jong, MC, Vries, JJ, Zonderhuis, BM, Eker, HH, Kazemier, G, Verheul, H, van der Meijs, BB, Dam, L, Sorgedrager, N, Coupé, VMH, van den Tol, PM, Meijerink, MR, Prevoo, W, Kok, N, Diederik, AL, Spaargaren, GJ, Sietses, C, van Heek, TNT, Serafino, G, Futterer, JJ, van den Boezem, PB, Stommel, M, de Wilt, H, Arntz, M, Jenniskens, S, Besselink, M, van Delden, OM, Gulik, TM, Tanis, PJ, van Lienden, KP, Burgmans, M C, Swijnenburg, RJ, van Erkel, AR, Hartgrink, HH, Peringa, J, Marsman, H, Jacobs, PC, Gerhards, MF, van der Leij, C, Brans, R, Coolsen, MME, Dejong, KCHC, Dam, R, Solouki, AM, Dol, JA, Vink, TWF, Manusama, ER, Patijn, GA, Nieuwenhuijs, VB, Meijer, MAJ, Torrenga, H, Sonneveld, EDJA, de Waard, JWD, Joosten, JJ, Verhoef, Kees, Moelker, Adriaan, Grunhagen, DJ, Groot Koerkamp, B, Hagendoorn, J, Molenaar, I, Bruijnen, RCG, van Nieuwkerk, KCMJ, van de Ven, P, Bakker, J, Leenders, MWH, Hellingman, T, van Grieken, N, Nieuwenhuizen, S, Geboers, B, Kuijk, C, de Wind, A, Anema, H, Breen, DJ, Aldrighetti, L, Cobelli, FD, Ratti, F, Marra, P, Albrecht, T, Muller, PD, Radiology and nuclear medicine, AGEM - Re-generation and cancer of the digestive system, CCA - Cancer Treatment and quality of life, Surgery, Medical oncology, Epidemiology and Data Science, APH - Methodology, ACS - Heart failure & arrhythmias, Pathology, Other Research, Public and occupational health, APH - Societal Participation & Health, Radiology & Nuclear Medicine, Puijk, Robbert S, Ruarus, Alette H, Vroomen, Laurien GPH, van Tilborg, Aukje AJM, Scheffer, Hester J, Nielsen, Karin, de Jong, Marcus C, de Vries, Jan JJ, Zonderhuis, Babs M, Eker, Hasan H, Kazemier, Geert, Verheul, Henk, van der Meijs, Bram B, van Dam, Laura, Sorgedrager, Natasha, Coupé, Veerle MH, van den Tol, Petrousjka MP, Meijerink, Martijn R, on behalf of COLLISION Trial, Group, Aldrighetti, Luca, De Cobelli, Francesco, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA - Imaging and biomarkers, CCA - Cancer Treatment and Quality of Life, ACS - Amsterdam Cardiovascular Sciences, Radiology and Nuclear Medicine, AGEM - Endocrinology, metabolism and nutrition, AGEM - Digestive immunity, and Graduate School
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Liver metastase ,Male ,Target lesion ,Cancer Research ,Colorectal cancer ,Radiofrequency ablation ,Colorectal Neoplasm ,030230 surgery ,law.invention ,Study Protocol ,Liver metastases ,Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14] ,0302 clinical medicine ,Randomized controlled trial ,Quality of life ,law ,Quality-Adjusted Life Year ,Clinical endpoint ,Medicine ,Colorectal liver metastases (CRLM) ,Liver Neoplasms ,Microwave ablation ,Microwave ablation (MWA) ,Middle Aged ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Treatment Outcome ,Liver ,Oncology ,Liver Neoplasm ,Urological cancers Radboud Institute for Health Sciences [Radboudumc 15] ,030220 oncology & carcinogenesis ,Catheter Ablation ,Female ,Quality-Adjusted Life Years ,Colorectal Neoplasms ,Human ,Adult ,medicine.medical_specialty ,lcsh:RC254-282 ,Disease-Free Survival ,03 medical and health sciences ,Genetic ,Genetics ,Humans ,Hepatectomy ,Liver surgery ,Aged ,business.industry ,Radiofrequency ablation (RFA) ,Other Research Radboud Institute for Health Sciences [Radboudumc 0] ,medicine.disease ,Hepatic resection ,Thermal ablation ,Surgery ,Clinical trial ,business - Abstract
Contains fulltext : 195648.pdf (Publisher’s version ) (Open Access) BACKGROUND: Radiofrequency ablation (RFA) and microwave ablation (MWA) are widely accepted techniques to eliminate small unresectable colorectal liver metastases (CRLM). Although previous studies labelled thermal ablation inferior to surgical resection, the apparent selection bias when comparing patients with unresectable disease to surgical candidates, the superior safety profile, and the competitive overall survival results for the more recent reports mandate the setup of a randomized controlled trial. The objective of the COLLISION trial is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable CRLM and no extrahepatic disease. METHODS: In this two-arm, single-blind multi-center phase-III clinical trial, six hundred and eighteen patients with at least one CRLM (
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- 2018
7. Colorectal liver metastases: Surgery versus thermal ablation (COLLISION) - a phase III single-blind prospective randomized controlled trial
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Puijk, RS, Ruarus, AH, Vroomen, LGPH, van Tilborg, AA, Scheffer, HJ, Nielsen, K, Jong, MC, Vries, JJ, Zonderhuis, BM, Eker, HH, Kazemier, G, Verheul, H, van der Meijs, BB, Dam, L, Sorgedrager, N, Coupé, VMH, van den Tol, PM, Meijerink, MR, Prevoo, W, Kok, N, Diederik, AL, Spaargaren, GJ, Sietses, C, van Heek, TNT, Serafino, G, Futterer, JJ, van den Boezem, PB, Stommel, M, de Wilt, H, Arntz, M, Jenniskens, S, Besselink, M, van Delden, OM, Gulik, TM, Tanis, PJ, van Lienden, KP, Burgmans, M C, Swijnenburg, RJ, van Erkel, AR, Hartgrink, HH, Peringa, J, Marsman, H, Jacobs, PC, Gerhards, MF, van der Leij, C, Brans, R, Coolsen, MME, Dejong, KCHC, Dam, R, Solouki, AM, Dol, JA, Vink, TWF, Manusama, ER, Patijn, GA, Nieuwenhuijs, VB, Meijer, MAJ, Torrenga, H, Sonneveld, EDJA, de Waard, JWD, Joosten, JJ, Verhoef, Kees, Moelker, Adriaan, Grunhagen, DJ, Groot Koerkamp, B, Hagendoorn, J, Molenaar, I, Bruijnen, RCG, van Nieuwkerk, KCMJ, van de Ven, P, Bakker, J, Leenders, MWH, Hellingman, T, van Grieken, N, Nieuwenhuizen, S, Geboers, B, Kuijk, C, de Wind, A, Anema, H, Breen, DJ, Aldrighetti, L, Cobelli, FD, Ratti, F, Marra, P, Albrecht, T, Muller, PD, Puijk, RS, Ruarus, AH, Vroomen, LGPH, van Tilborg, AA, Scheffer, HJ, Nielsen, K, Jong, MC, Vries, JJ, Zonderhuis, BM, Eker, HH, Kazemier, G, Verheul, H, van der Meijs, BB, Dam, L, Sorgedrager, N, Coupé, VMH, van den Tol, PM, Meijerink, MR, Prevoo, W, Kok, N, Diederik, AL, Spaargaren, GJ, Sietses, C, van Heek, TNT, Serafino, G, Futterer, JJ, van den Boezem, PB, Stommel, M, de Wilt, H, Arntz, M, Jenniskens, S, Besselink, M, van Delden, OM, Gulik, TM, Tanis, PJ, van Lienden, KP, Burgmans, M C, Swijnenburg, RJ, van Erkel, AR, Hartgrink, HH, Peringa, J, Marsman, H, Jacobs, PC, Gerhards, MF, van der Leij, C, Brans, R, Coolsen, MME, Dejong, KCHC, Dam, R, Solouki, AM, Dol, JA, Vink, TWF, Manusama, ER, Patijn, GA, Nieuwenhuijs, VB, Meijer, MAJ, Torrenga, H, Sonneveld, EDJA, de Waard, JWD, Joosten, JJ, Verhoef, Kees, Moelker, Adriaan, Grunhagen, DJ, Groot Koerkamp, B, Hagendoorn, J, Molenaar, I, Bruijnen, RCG, van Nieuwkerk, KCMJ, van de Ven, P, Bakker, J, Leenders, MWH, Hellingman, T, van Grieken, N, Nieuwenhuizen, S, Geboers, B, Kuijk, C, de Wind, A, Anema, H, Breen, DJ, Aldrighetti, L, Cobelli, FD, Ratti, F, Marra, P, Albrecht, T, and Muller, PD
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- 2018
8. Are we SHARP enough? The importance of adequate patient selection in sorafenib treatment for hepatocellular carcinoma
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Labeur, TA, ten Cate, DWG (David), Takkenberg, RB, Azahaf, H, van Oijen, MGH, van Delden, OM, de Man, Rob, van Vugt, Jeroen, IJzermans, JNM, Eskens, Ferry, Klumpen, HJ, Labeur, TA, ten Cate, DWG (David), Takkenberg, RB, Azahaf, H, van Oijen, MGH, van Delden, OM, de Man, Rob, van Vugt, Jeroen, IJzermans, JNM, Eskens, Ferry, and Klumpen, HJ
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- 2018
9. Variable efficacy of TIPSS in the management of ectopic variceal bleeding: a multicentre retrospective study
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Oey, Rosalie, de Wit, K, Moelker, Adriaan, Atalik, Tuğçe, van Delden, OM, Maleux, G, Erler, Nicole, Takkenberg, RB, de Man, Rob, Nevens, F, van Buuren, Henk, Oey, Rosalie, de Wit, K, Moelker, Adriaan, Atalik, Tuğçe, van Delden, OM, Maleux, G, Erler, Nicole, Takkenberg, RB, de Man, Rob, Nevens, F, and van Buuren, Henk
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- 2018
10. Hepatocellular carcinoma: Dutch guideline for surveillance, diagnosis and therapy
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Eskens, Ferry, van Erpecum, KJ, de Jong, KP, van Delden, OM, Klumpen, HJ, Verhoef, Kees, Jansen, PLM, van den Bosch, MAAJ, Mendez Romero, Alejandra, Verheij, J, Bloemena, E, de Man, Rob, Medical Oncology, Surgery, Radiotherapy, and Gastroenterology & Hepatology
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SDG 3 - Good Health and Well-being ,neoplasms ,digestive system diseases - Abstract
Hepatocellular carcinoma (HCC) is rare in the Netherlands, even though the incidence has increased quite sharply in recent years. Standard treatment options consist of surgery, orthotopic liver transplantation, radiofrequency ablation, transarterial chemoembolisation (TACE) and systemic therapy with sorafenib. The consensus-based Dutch HCC guideline, established in 2013, serves to guide surveillance, diagnosis and treatment options: Surveillance should be performed by ultrasound at six-month intervals in well-defined cirrhotic patients and in selected high-risk hepatitis B carriers; A nodule > 1 cm in cirrhotic patients with arterial hypervascularity and venous or delayed phase washout at four-phase CT or MRI scan establishes the diagnosis of HCC; In patients with HCC without underlying cirrhosis, resection should be considered regardless of tumour size; In cirrhotic HCC patients, tumour stage, severity of underlying cirrhosis, and performance status determine treatment options. The algorithm of the Barcelona Clinic Liver Cancer (BCLC) staging system should be followed; Patients with Child-Pugh A-B cirrhosis (CP < 8 points) and performance status 0-2 are candidates for any active treatment other than transplantation; In early stage HCC (BCLC stage 0 or A, compensated cirrhosis without portal hypertension) surgical resection, liver transplantation, or radiofrequency ablation should be considered; In intermediate stage HCC (BCLC stage B) TACE and/or radiofrequency ablation should be considered; In advanced stage HCC (BCLC stage C) sorafenib should be considered. Conclusion: The Dutch HCC guideline offers advice for surveillance, diagnosis and treatment of HCC.
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- 2014
11. Preoperative endoscopic versus percutaneous transhepatic biliary drainage in potentially resectable perihilar cholangiocarcinoma (DRAINAGE trial): design and rationale of a randomized controlled trial
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Wiggers, JK, Coelen, RJS, Rauws, EAJ, van Delden, OM, van Eijck, Casper, de Jonge, Jeroen, Porte, RJ, Buis, CI, Dejong, CHC, Molenaar, IQ, Besselink, MGH, Busch, ORC, Dijkgraaf, MGW, Gulik, TM, Wiggers, JK, Coelen, RJS, Rauws, EAJ, van Delden, OM, van Eijck, Casper, de Jonge, Jeroen, Porte, RJ, Buis, CI, Dejong, CHC, Molenaar, IQ, Besselink, MGH, Busch, ORC, Dijkgraaf, MGW, and Gulik, TM
- Abstract
Background: Liver surgery in perihilar cholangiocarcinoma (PHC) is associated with high postoperative morbidity because the tumor typically causes biliary obstruction. Preoperative biliary drainage is used to create a safer environment prior to liver surgery, but biliary drainage may be harmful when severe drainage-related complications deteriorate the patients' condition or increase the risk of postoperative morbidity. Biliary drainage can cause cholangitis/cholecystitis, pancreatitis, hemorrhage, portal vein thrombosis, bowel wall perforation, or dehydration. Two methods of preoperative biliary drainage are mostly applied: endoscopic biliary drainage, which is currently used in most regional centers before referring patients for surgical treatment, and percutaneous transhepatic biliary drainage. Both methods are associated with severe drainage-related complications, but two small retrospective series found a lower incidence in the number of preoperative complications after percutaneous drainage compared to endoscopic drainage (18-25% versus 38-60%, respectively). The present study randomizes patients with potentially resectable PHC and biliary obstruction between preoperative endoscopic or percutaneous transhepatic biliary drainage. Methods/Design: The study is a multi-center trial with an "all-comers" design, randomizing patients between endoscopic or percutaneous transhepatic biliary drainage. All patients selected to potentially undergo a major liver resection for presumed PHC are eligible for inclusion in the study provided that the biliary system in the future liver remnant is obstructed (even if they underwent previous inadequate endoscopic drainage). Primary outcome measure is the total number of severe preoperative complications between randomization and exploratory laparotomy. The study is designed to detect superiority of percutaneous drainage: a provisional sample size of 106 patients is required to detect a relative decrease of 50% in the number of sev
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- 2015
12. Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration ( DROP-trial)
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van der Gaag, NA, de Castro, SM, Rauws, EAJ, Bruno, Marco, van Eijck, Casper, Kuipers, Ernst, Gerritsen, JJ, Rutten, JP, Greve, JW, Hesselink, EJ (Eric), Klinkenbijl, JH, Rinkes, IH, Boerma, D, Bonsing, BA, van Laarhoven, CJ, Kubben, FJ, van der Harst, E (Erwin), Sosef, MN, Bosscha, K, de Hingh, IH, de Wit, L, van Delden, OM, Busch, ORC, Gulik, TM, Bossuyt, PMM, Gouma, DJ, van der Gaag, NA, de Castro, SM, Rauws, EAJ, Bruno, Marco, van Eijck, Casper, Kuipers, Ernst, Gerritsen, JJ, Rutten, JP, Greve, JW, Hesselink, EJ (Eric), Klinkenbijl, JH, Rinkes, IH, Boerma, D, Bonsing, BA, van Laarhoven, CJ, Kubben, FJ, van der Harst, E (Erwin), Sosef, MN, Bosscha, K, de Hingh, IH, de Wit, L, van Delden, OM, Busch, ORC, Gulik, TM, Bossuyt, PMM, and Gouma, DJ
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- 2007
13. Portal vein embolization before liver resection: a systematic review.
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van Lienden KP, van den Esschert JW, de Graaf W, Bipat S, Lameris JS, van Gulik TM, van Delden OM, van Lienden, K P, van den Esschert, J W, de Graaf, W, Bipat, S, Lameris, J S, van Gulik, T M, and van Delden, O M
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Purpose: This is a review of literature on the indications, technique, and outcome of portal vein embolization (PVE).Methods: A systematic literature search on outcome of PVE from 1990 to 2011 was performed in Medline, Cochrane, and Embase databases.Results: Forty-four articles were selected, including 1,791 patients with a mean age of 61 ± 4.1 years. Overall technical success rate was 99.3 %. The mean hypertrophy rate of the FRL after PVE was 37.9 ± 0.1 %. In 70 patients (3.9 %), surgery was not performed because of failure of PVE (clinical success rate 96.1 %). In 51 patients (2.8 %), the hypertrophy response was insufficient to perform liver resection. In the other 17 cases, 12 did not technically succeed (0.7 %) and 7 caused a complication leading to unresectability (0.4 %). In 6.1 %, resection was cancelled because of local tumor progression after PVE. Major complications were seen in 2.5 %, and the mortality rate was 0.1 %. A head-to-head comparison shows a negative effect of liver cirrhosis on hypertrophy response. The use of n-butyl cyanoacrylate seems to have a greater effect on hypertrophy, but the difference with other embolization materials did not reach statistical significance. No difference in regeneration is seen in patients with cholestasis or chemotherapy.Conclusions: Preoperative PVE has a high technical and clinical success rate. Liver cirrhosis has a negative effect on regeneration, but cholestasis and chemotherapy do not seem to have an influence on the hypertrophy response. The use of n-butyl cyanoacrylate may result in a greater hypertrophy response compared with other embolization materials used. [ABSTRACT FROM AUTHOR]- Published
- 2013
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14. Literature review of the role of ultrasound, computed tomography, and transcatheter arterial embolization for the treatment of traumatic splenic injuries.
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van der Vlies CH, van Delden OM, Punt BJ, Ponsen KJ, Reekers JA, Goslings JC, van der Vlies, Cornelis H, van Delden, Otto M, Punt, Bastiaan J, Ponsen, Kees J, Reekers, Jim A, and Goslings, J Carel
- Abstract
Introduction: The spleen is the second most frequently injured organ following blunt abdominal trauma. Trends in management have changed over the years. Traditionally, laparotomy and splenectomy was the standard management. Presently, nonoperative management (NOM) of splenic injury is the most common management strategy in hemodynamically stable patients. Splenic injuries can be managed via simple observation (OBS) or with angiography and embolization (AE). Angio-embolization has shown to be a valuable alternative to observational management and has increased the success rate of nonoperative management in many series.Diagnostics: Improved imaging techniques and advances in interventional radiology have led to a better selection of patients who are amenable to nonoperative management. Despite this, there is still a lot of debate about which patients are prone to NOM.Angiography and Embolization: The optimal patient selection is still a matter of debate and the role of CT and angio-embolization has not yet fully evolved. We discuss the role of sonography and CT features, such as contrast extravasation, pseudoaneurysms, arteriovenous fistulas, or hemoperitoneum, to determine the optimal patient selection for angiography and embolization. We also review the efficiency, technical considerations (proximal or selective embolization), logistics, and complication rates of AE for blunt traumatic splenic injuries. [ABSTRACT FROM AUTHOR]- Published
- 2010
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15. Endovascular thrombectomy and thrombolysis for severe cerebral sinus thrombosis: a prospective study.
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Stam J, Majoie CB, van Delden OM, van Lienden KP, Reekers JA, Stam, Jan, Majoie, Charles B L M, van Delden, Otto M, van Lienden, Krijn P, and Reekers, Jim A
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- 2008
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16. Extrahepatic perfusion and incomplete hepatic perfusion after hepatic arterial infusion pump implantation: incidence and clinical implications.
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Filipe WF, Buisman FE, Franssen S, Krul MF, Grünhagen DJ, Bennink RJ, Bolhuis K, Bruijnen RCG, Buffart TE, Burgmans MC, van Delden OM, Doornebosch PG, Gobardhan PD, Graven L, de Groot JWB, Grootscholten C, Hagendoorn J, Harmsen P, Homs MYV, Klompenhouwer EG, Kok NFM, Lam MGEH, Loosveld OJL, Meier MAJ, Mieog JSD, Oostdijk AHJ, Outmani L, Patijn GA, Pool S, Rietbergen DDD, Roodhart JML, Speetjens FM, Swijnenburg RJ, Versleijen MWJ, Verhoef C, Kuhlmann KFD, Moelker A, and Groot Koerkamp B
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- Aged, Female, Humans, Male, Middle Aged, Antineoplastic Agents administration & dosage, Incidence, Infusion Pumps, Implantable, Liver Circulation, Liver Neoplasms surgery, Methylene Blue administration & dosage, Netherlands epidemiology, Retrospective Studies, Single Photon Emission Computed Tomography Computed Tomography, Technetium Tc 99m Aggregated Albumin administration & dosage, Hepatic Artery diagnostic imaging, Infusions, Intra-Arterial
- Abstract
Introduction: This study investigates the incidence of extrahepatic perfusion and incomplete hepatic perfusion at intraoperative methylene blue testing and on postoperative nuclear imaging in patients undergoing hepatic arterial infusion pump (HAIP) chemotherapy., Methods: The first 150 consecutive patients who underwent pump implantation in the Netherlands were included. All patients underwent surgical pump implantation with the catheter in the gastroduodenal artery. All patients underwent intraoperative methylene blue testing and postoperative nuclear imaging (
99m Tc-Macroaggregated albumin SPECT/CT) to determine perfusion via the pump., Results: Patients were included between January-2018 and December-2021 across eight centers. During methylene blue testing, 29.3% had extrahepatic perfusion, all successfully managed intraoperatively. On nuclear imaging, no clinically relevant extrahepatic perfusion was detected (0%, 95%CI: 0.0-2.5%). During methylene blue testing, 2.0% had unresolved incomplete hepatic perfusion. On postoperative nuclear imaging, 8.1% had incomplete hepatic perfusion, leading to embolization in only 1.3%., Conclusion: Methylene blue testing during pump placement for intra-arterial chemotherapy identified extrahepatic perfusion in 29.3% of patients, but could be resolved intraoperatively in all patients. Postoperative nuclear imaging found no clinically relevant extrahepatic perfusion and led to embolization in only 1.3% of patients. The role of routine nuclear imaging after HAIP implantation should be studied in a larger cohort., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)- Published
- 2024
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17. Lesions hyper- to isointense to surrounding liver in the hepatobiliary phase of gadoxetic acid-enhanced MRI.
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Furumaya A, Willemssen FEJA, Miclea RL, Haring MPD, de Haas RJ, Feshtali S, Vanhooymissen IJS, Bos D, de Man RA, Ijzermans JNM, Erdmann JI, Verheij J, Doukas MC, van Delden OM, and Thomeer MGJ
- Abstract
Objectives: Hyper- or isointensity in the hepatobiliary phase (HBP) of gadoxetic acid-enhanced MRI has high specificity for focal nodular hyperplasia (FNH) but may be present in hepatocellular adenoma and carcinoma (HCA/HCC). This study aimed to identify imaging characteristics differentiating FNH and HCA/HCC., Materials and Methods: This multicenter retrospective cohort study included patients with pathology-proven FNH or HCA/HCC, hyper-/isointense in the HBP of gadoxetic acid-enhanced MRI between 2010 and 2020. Diagnostic performance of imaging characteristics for the differentiation between FNH and HCA/HCC were reported. Univariable analyses, multivariable logistic regression analyses, and classification and regression tree (CART) analyses were conducted. Sensitivity analyses evaluated imaging characteristics of B-catenin-activated HCA., Results: In total, 124 patients (mean age 40 years, standard deviation 10 years, 108 female) with 128 hyper-/isointense lesions were included. Pathology diagnoses were FNH and HCA/HCC in 64 lesions (50%) and HCA/HCC in 64 lesions (50%). Imaging characteristics observed exclusively in HCA/HCC were raster and atoll fingerprint patterns in the HBP, sinusoidal dilatation on T2-w, hemosiderin, T1-w in-phase hyperintensity, venous washout, and nodule-in-nodule partification in the HBP and T2-w. Multivariable logistic regression and CART additionally found a T2-w scar indicating FNH, less than 50% fat, and a spherical contour indicating HCA/HCC. In our selected cohort, 14/48 (29%) of HCA were B-catenin activated, most (13/14) showed extensive hyper-/isointensity, and some had a T2-w scar (4/14, 29%)., Conclusion: If the aforementioned characteristics typical for HCA/HCC are encountered in lesions extensively hyper- to isointense, further investigation may be warranted to exclude B-catenin-activated HCA., Clinical Relevance: Hyper- or isointensity in the HBP of gadoxetic acid-enhanced MRI is specific for FNH, but HCA/HCC can also exhibit this feature. Therefore, we described imaging patterns to differentiate these entities., Key Points: FNH and HCA/HCC have similar HBP intensities but have different malignant potentials. Six imaging patterns exclusive to HCA/HCC were identified in this lesion population. These features in liver lesions hyper- to isointense in the HBP warrant further evaluation., (© 2024. The Author(s).)
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- 2024
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18. Adjuvant holmium-166 radioembolization after radiofrequency ablation in early-stage hepatocellular carcinoma patients: a dose-finding study (HORA EST HCC trial).
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Hendriks P, Rietbergen DDD, van Erkel AR, Coenraad MJ, Arntz MJ, Bennink RJ, Braat AE, Crobach S, van Delden OM, Dibbets-Schneider P, van der Hulle T, Klümpen HJ, van der Meer RW, Nijsen JFW, van Rijswijk CSP, Roosen J, Ruijter BN, Smit F, Stam MK, Takkenberg RB, Tushuizen ME, van Velden FHP, de Geus-Oei LF, and Burgmans MC
- Subjects
- Humans, Male, Female, Aged, Middle Aged, Radiofrequency Ablation methods, Radiotherapy Dosage, Neoplasm Staging, Tissue Distribution, Carcinoma, Hepatocellular radiotherapy, Carcinoma, Hepatocellular therapy, Carcinoma, Hepatocellular diagnostic imaging, Liver Neoplasms radiotherapy, Liver Neoplasms therapy, Holmium therapeutic use, Embolization, Therapeutic methods, Radioisotopes therapeutic use, Radioisotopes administration & dosage
- Abstract
Purpose: The aim of this study was to investigate the biodistribution of (super-)selective trans-arterial radioembolization (TARE) with holmium-166 microspheres (
166 Ho-MS), when administered as adjuvant therapy after RFA of HCC 2-5 cm. The objective was to establish a treatment volume absorbed dose that results in an absorbed dose of ≥ 120 Gy on the hyperemic zone around the ablation necrosis (i.e., target volume)., Methods: In this multicenter, prospective dose-escalation study in BCLC early stage HCC patients with lesions 2-5 cm, RFA was followed by (super-)selective infusion of166 Ho-MS on day 5-10 after RFA. Dose distribution within the treatment volume was based on SPECT-CT. Cohorts of up to 10 patients were treated with an incremental dose (60 Gy, 90 Gy, 120 Gy) of166 Ho-MS to the treatment volume. The primary endpoint was to obtain a target volume dose of ≥ 120 Gy in 9/10 patients within a cohort., Results: Twelve patients were treated (male 10; median age, 66.5 years (IQR, [64.3-71.7])) with a median tumor diameter of 2.7 cm (IQR, [2.1-4.0]). At a treatment volume absorbed dose of 90 Gy, the primary endpoint was met with a median absorbed target volume dose of 138 Gy (IQR, [127-145]). No local recurrences were found within 1-year follow-up., Conclusion: Adjuvant (super-)selective infusion of166 Ho-MS after RFA for the treatment of HCC can be administered safely at a dose of 90 Gy to the treatment volume while reaching a dose of ≥ 120 Gy to the target volume and may be a favorable adjuvant therapy for HCC lesions 2-5 cm., Trial Registration: Clinicaltrials.gov NCT03437382 . (registered: 19-02-2018)., (© 2024. The Author(s).)- Published
- 2024
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19. Hybrid operating room applications for precision hepatobiliary surgery: A narrative review.
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Pilz da Cunha G, van Delden OM, Kazemier G, Vahrmeijer AL, Bonjer HJ, Meijerink MR, and Swijnenburg RJ
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- Humans, Surgery, Computer-Assisted methods, Liver Neoplasms surgery, Biliary Tract Surgical Procedures methods, Operating Rooms
- Abstract
This review summarizes the key applications of a hybrid operating room (HOR) in hepatobiliary surgery and explores the advantages, limitations, and future directions of its utilization. A comprehensive literature search was conducted in PubMed to identify articles reporting on the utilization of HORs in liver surgery. So far, the HOR has been limitedly applied in hepatobiliary surgery. It can offer an optimal environment for combining radiological and surgical interventions and for performing image-guided surgical navigation., (© 2024 The Authors. Journal of Surgical Oncology published by Wiley Periodicals LLC.)
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- 2024
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20. Effect of Sarcopenia on the Increase in Liver Volume and Function After Portal Vein Embolization.
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Arntz PJW, Olthof PB, Korenblik R, Heil J, Kazemier G, van Delden OM, Bennink RJ, Damink SWMO, van Dam RM, Schadde E, and Erdmann JI
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- Humans, Male, Female, Middle Aged, Aged, Organ Size, Retrospective Studies, Liver Regeneration physiology, Sarcopenia diagnostic imaging, Portal Vein diagnostic imaging, Embolization, Therapeutic methods, Liver diagnostic imaging, Tomography, X-Ray Computed methods
- Abstract
Purpose: Sarcopenia is associated with a decreased kinetic growth rate (KGR) of the future liver remnant (FLR) after portal vein embolization (PVE). However, little is known on the increase in FLR function (FLRF) after PVE. This study evaluated the effect of sarcopenia on the functional growth rate (FGR) after PVE measured with hepatobiliary scintigraphy (HBS)., Methods: All patients who underwent PVE at the Amsterdam UMC between January 2005 and August 2017 were analyzed. Functional imaging by HBS was used to determine FGR. Liver volumetry was performed using multiphase contrast computed tomography (CT). Muscle area measurement to determine sarcopenia was taken at the third lumbar level (L3)., Results: Out of the 95 included patients, 9 were excluded due to unavailable data. 70/86 (81%) patients were sarcopenic. In the multivariate logistic regression analysis, sarcopenia (p = 0.009) and FLR volume (FRLV) before PVE (p = 0.021) were the only factors correlated with KGR, while no correlation was found with FGR. 90-day mortality was similar across the sarcopenic and non-sarcopenic group (4/53 [8%] versus 1/11 [9%]; p = 1.000). The resection rates were also comparable (53/70 [75%] versus 11/16 [69%]; p = 0.542)., Conclusion: FGR after PVE as measured by HBS appears to be preserved in sarcopenic patients. This is in contrast to KGR after PVE as measured by liver volumetry which is decreased in sarcopenic patients., Level of Evidence: Level 3b, cohort and case control studies., (© 2024. The Author(s).)
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- 2024
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21. Recurrent cholangitis in patients with a non-stenotic hepaticojejunostomy: incidence and risk factors.
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Overdevest AG, Fritzsche JA, Smit MAD, Besselink MG, Bonomi AM, Busch OR, Daams F, van Delden OM, Kazemier G, Langver J, Ponsioen CY, Swijnenburg RJ, van Wanrooij RLJ, Wielenga MCB, Zonderhuis BM, Zijlstra IAJ, Erdmann JI, and Voermans RP
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- Humans, Male, Retrospective Studies, Constriction, Pathologic etiology, Constriction, Pathologic surgery, Incidence, Anastomosis, Surgical, Risk Factors, Treatment Outcome, Postoperative Complications etiology, Cholangitis etiology, Cholangitis complications
- Abstract
Background: Cholangitis is a well-known complication after hepaticojejunostomy (HJ), which is mainly caused by a stenotic anastomosis. However, the rate of cholangitis in patients with a non-stenotic (i.e. patent) HJ is unknown. We aimed to evaluate the incidence and risk factors of recurrent cholangitis in patients with a non-stenotic HJ., Methods: This single-center retrospective cohort study included all consecutive patients who had undergone hepatobiliary or pancreatic (HPB) surgery requiring HJ (2015-2022). Primary outcome was recurrent non-stenotic cholangitis, risk factors for recurrent non-stenotic cholangitis were identified using logistic regression., Results: Overall, 835 patients with a HJ were included of whom 31/698 (4.4%) patients developed recurrent cholangitis with a non-stenotic HJ during a median follow-up of 34 months (IQR 22-50) and 98/796 (12.3%) patients developed a symptomatic HJ stenosis. These 31 patients experienced 205 cholangitis episodes, median 7.0 (IQR 3.8-8.8) per patient, and 71/205 (34.6%) cholangitis episodes required hospitalization. Male sex (aOR 3.17 (95% CI: 1.34-7.49)) and benign disease (aOR 2.97, 95% CI 1.40-6.33) were identified as risk factors for recurrent cholangitis in non-stenotic HJ in both univariate and multivariable analysis., Conclusion: This study shows that 4% of patients developed recurrent cholangitis without an underlying HJ stenosis., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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22. Diagnosis and treatment of patients with suspected mucinous cystic neoplasms of the liver: a retrospective cohort study.
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Furumaya A, Schulz HH, Verheij J, Takkenberg RB, Besselink MG, Kazemier G, Erdmann JI, and van Delden OM
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- Humans, Retrospective Studies, Pancreatic Neoplasms pathology, Neoplasms, Cystic, Mucinous, and Serous, Cysts, Liver Neoplasms diagnostic imaging, Liver Neoplasms surgery
- Abstract
Purpose: Mucinous cystic neoplasms of the liver (MCN-L) are hepatic cysts with a low malignant potential. The recent European Association for the Study of the Liver (EASL) guidelines provide guidance on the imaging features and surgical management of MCN-L, yet are hampered by a lack of studies adhering to the revised World Health Organization (WHO) criteria. This study attempted to validate the new 2022 EASL-guidelines in a retrospective cohort study of patients who underwent surgery for suspected MCN-L., Methods: Patients undergoing surgery for suspected MCN-L in a single center between 2010 and 2020 were included. Imaging features were assessed according to the EASL guidelines and were compared to final pathological diagnoses, according to the WHO criteria., Results: In total, 35 patients were included. In three patients, there were no worrisome imaging features, yet final pathological diagnosis showed MCN-L. Contrarily, six patients with worrisome imaging features did not have MCN-L. Five patients were diagnosed with MCN-L on final pathology. The sensitivity of the EASL-guidelines for the diagnosis of MCN-L was 40% (95%CI: 5.3-85%) and the specificity was 80% (95% CI: 61-92%)., Conclusion: Although the new EASL-guidelines provide some guidance, they could not reliably distinguish MCN-L from other cysts in our series. Thus, preoperative diagnosis of MCN-L remains challenging and we should be careful in selecting surgical strategies based on these criteria., (© 2024. The Author(s).)
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- 2024
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23. Association Between Gadoxetic Acid-Enhanced Magnetic Resonance Imaging, Organic Anion Transporters, and Farnesoid X Receptor in Benign Focal Liver Lesions.
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van Rosmalen BV, Visentin M, Furumaya A, van Delden OM, Kazemier G, van Gulik TM, Verheij J, and Stieger B
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- Humans, Contrast Media metabolism, Magnetic Resonance Imaging methods, Multidrug Resistance-Associated Protein 2, Anions metabolism, Retrospective Studies, Organic Anion Transporters metabolism, Liver Neoplasms diagnostic imaging, Liver Neoplasms metabolism, Adenoma, Liver Cell, Focal Nodular Hyperplasia diagnosis, Focal Nodular Hyperplasia metabolism, Focal Nodular Hyperplasia pathology
- Abstract
The organic anion uptake and efflux transporters [organic anion-transporting polypeptide (OATP)1B1, OATP1B3 and multidrug resistance-associated protein (MRP)2 and MRP3] that mediate the transport of the hepatobiliary-specific contrast agent gadoxetate (Gd-EOB-DTPA) are direct or indirect targets of the farnesoid X receptor (FXR), a key regulator of bile acid and lipid homeostasis. In benign liver tumors, FXR expression and activation is not yet characterized. We investigated the expression and activation of FXR and its targets in hepatocellular adenoma (HCA) and focal nodular hyperplasia (FNH) and their correlation with Gd-EOB-DTPA-enhanced magnetic resonance imaging (MRI). Gd-EOB-DTPA MRI patterns were assessed by an expert radiologist. The intensity of the lesions on the hepatobiliary phase was correlated to mRNA expression levels of OATP1B1, OATP1B3, MRP2, MRP3, FXR, and small heterodimer partner (SHP) in fresh surgical specimens of patients with FNH or HCA subtypes. Normal and tumor sample pairs of 43 HCA and 14 FNH were included. All FNH (14/14) were hyperintense. Of the 34 HCA with available Gd-EOB-DTPA-enhanced MRI, 6 were hyperintense and 28 HCA were hypointense. OATP1B3 was downregulated in the hypointense tumors compared with normal surrounding liver tissue (2.77±3.59 vs. 12.9±15.6, P < 0.001). A significant positive correlation between FXR expression and activation and OATP1B3 expression level was found in the HCA cohort. SHP showed a trend toward downregulation in hypointense HCA. In conclusion, this study suggests that the MRI relative signal in HCA may reflect expression level and/or activity of SHP and FXR. Moreover, our data confirms the pivotal role of OATP1B3 in Gd-EOB-DTPA uptake in HCA. SIGNIFICANCE STATEMENT: FXR represents a valuable target for the treatment of liver disease and metabolic syndrome. Currently, two molecules, ursodeoxycholate and obeticholate, are approved for the treatment of primary biliary cirrhosis and cholestasis, with several compounds in clinical trials for the treatment of metabolic dysfunction-associated fatty liver disease. Because FXR expression and activation is associated with gadoxetate accumulation in HCA, an atypical gadoxetate-enhanced MRI pattern might arise in patients under FXR-targeted therapy, thereby complicating the differential diagnosis., (Copyright © 2024 by The American Society for Pharmacology and Experimental Therapeutics.)
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- 2024
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24. MRI in addition to CT in patients scheduled for local therapy of colorectal liver metastases (CAMINO): an international, multicentre, prospective, diagnostic accuracy trial.
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Görgec B, Hansen IS, Kemmerich G, Syversveen T, Abu Hilal M, Belt EJT, Bosscha K, Burgmans MC, Cappendijk VC, D'Hondt M, Edwin B, van Erkel AR, Gielkens HAJ, Grünhagen DJ, Gobardhan PD, Hartgrink HH, Horsthuis K, Klompenhouwer EG, Kok NFM, Kint PAM, Kuhlmann K, Leclercq WKG, Lips DJ, Lutin B, Maas M, Marsman HA, Meijerink M, Meyer Y, Morone M, Peringa J, Sijberden JP, van Delden OM, van den Bergh JE, Vanhooymissen IJS, Vermaas M, Willemssen FEJA, Dijkgraaf MGW, Bossuyt PM, Swijnenburg RJ, Fretland ÅA, Verhoef C, Besselink MG, and Stoker J
- Subjects
- Male, Female, Humans, Contrast Media, Prospective Studies, Tomography, X-Ray Computed methods, Magnetic Resonance Imaging methods, Liver Neoplasms diagnostic imaging, Liver Neoplasms therapy, Liver Neoplasms pathology, Colorectal Neoplasms diagnostic imaging, Colorectal Neoplasms therapy, Colorectal Neoplasms pathology
- Abstract
Background: Guidelines are inconclusive on whether contrast-enhanced MRI using gadoxetic acid and diffusion-weighted imaging should be added routinely to CT in the investigation of patients with colorectal liver metastases who are scheduled for curative liver resection or thermal ablation, or both. Although contrast-enhanced MRI is reportedly superior than contrast-enhanced CT in the detection and characterisation of colorectal liver metastases, its effect on clinical patient management is unknown. We aimed to assess the clinical effect of an additional liver contrast-enhanced MRI on local treatment plan in patients with colorectal liver metastases amenable to local treatment, based on contrast-enhanced CT., Methods: We did an international, multicentre, prospective, incremental diagnostic accuracy trial in 14 liver surgery centres in the Netherlands, Belgium, Norway, and Italy. Participants were aged 18 years or older with histological proof of colorectal cancer, a WHO performance status score of 0-4, and primary or recurrent colorectal liver metastases, who were scheduled for local therapy based on contrast-enhanced CT. All patients had contrast-enhanced CT and liver contrast-enhanced MRI including diffusion-weighted imaging and gadoxetic acid as a contrast agent before undergoing local therapy. The primary outcome was change in the local clinical treatment plan (decided by the individual clinics) on the basis of liver contrast-enhanced MRI findings, analysed in the intention-to-image population. The minimal clinically important difference in the proportion of patients who would have change in their local treatment plan due to an additional liver contrast-enhanced MRI was 10%. This study is closed and registered in the Netherlands Trial Register, NL8039., Findings: Between Dec 17, 2019, and July 31, 2021, 325 patients with colorectal liver metastases were assessed for eligibility. 298 patients were enrolled and included in the intention-to-treat population, including 177 males (59%) and 121 females (41%) with planned local therapy based on contrast-enhanced CT. A change in the local treatment plan based on liver contrast-enhanced MRI findings was observed in 92 (31%; 95% CI 26-36) of 298 patients. Changes were made for 40 patients (13%) requiring more extensive local therapy, 11 patients (4%) requiring less extensive local therapy, and 34 patients (11%) in whom the indication for curative-intent local therapy was revoked, including 26 patients (9%) with too extensive disease and eight patients (3%) with benign lesions on liver contrast-enhanced MRI (confirmed by a median follow-up of 21·0 months [IQR 17·5-24·0])., Interpretation: Liver contrast-enhanced MRI should be considered in all patients scheduled for local treatment for colorectal liver metastases on the basis of contrast-enhanced CT imaging., Funding: The Dutch Cancer Society and Bayer AG - Pharmaceuticals., Competing Interests: Declaration of interests BE received honoraria from Medtronic for lectures. KH has a leadership role in the Dutch Colorectal Cancer group. DJL received honoraria from Intuitive surgical. MMa received support for travel to attend the following courses where she gave lectures: ECIO 2023, ESGAR Liver Imaging workshop, and Alimentary tract cancer course New York 2023. MMe received grants from Medtronic–Covidien, Johnson & Johnson, Immunophotonics, and Angiodynamics. MMe also received consulting fees from Angiodynamics and Medtronic–Covidien; honoraria from Medtronic–Covidien, Johnson & Johnson, and Angiodynamics; and support for attending meetings from Angiodynamics. MMe is participating in the Data Safety and Monitoring Board of the Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced uveal melanoma trial and had leadership or fiduciary roles in the Society of Interventional Oncology, CIRSE & ECIO, and CVIR. ÅAF received honoraria from Bayer AG, Olympus Healthcare, and Siemens Healthineers. JS received funding from the Dutch Cancer Society (grant number 11916) and is president-elect of the European Society of Gastrointestinal and Abdominal Radiology. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)
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- 2024
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25. Endobiliary radiofrequency ablation combined with metal stents for malignant biliary obstruction due to perihilar cholangiocarcinoma (RACCOON-p): a prospective pilot study.
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Fritzsche JA, Wielenga MCB, Van Delden OM, Erdmann JI, Fockens P, Klümpen HJ, Ponsioen CY, Van Wanrooij RLJ, and Voermans RP
- Subjects
- Animals, Pilot Projects, Raccoons, Prospective Studies, Stents, Bile Ducts, Intrahepatic surgery, Treatment Outcome, Klatskin Tumor complications, Klatskin Tumor surgery, Radiofrequency Ablation, Cholangiocarcinoma surgery, Bile Duct Neoplasms complications, Bile Duct Neoplasms surgery, Cholestasis diagnostic imaging, Cholestasis etiology, Cholestasis surgery, Catheter Ablation
- Published
- 2023
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26. Transarterial Chemoembolization With Drug-Eluting Beads Versus Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma: Outcomes From a Multicenter, Randomized, Phase 2 Trial (the TRENDY Trial).
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Méndez Romero A, van der Holt B, Willemssen FEJA, de Man RA, Heijmen BJM, Habraken S, Westerveld H, van Delden OM, Klümpen HJ, Tjwa ETTL, Braam PM, Jenniskens SFM, Vanwolleghem T, Weytjens R, d'Archambeau O, de Vos-Geelen J, Buijsen J, van der Leij C, den Toom W, Sprengers D, IJzermans JNM, and Moelker A
- Subjects
- Humans, Quality of Life, Radiosurgery adverse effects, Carcinoma, Hepatocellular radiotherapy, Chemoembolization, Therapeutic, Liver Neoplasms radiotherapy
- Abstract
Purpose: To compare transarterial chemoembolization delivered with drug eluting beads (TACE-DEB) with stereotactioc body radiation therapy (SBRT) in patients with hepatocellular carcinoma (HCC) in a multicenter randomized trial., Methods and Materials: Patients were included if they were eligible for TACE. They could also be recruited if they required treatment prior to liver transplantation. A maximum of four TACE-DEB procedures and ablation after incomplete TACE-DEB were both allowed. SBRT was delivered in six fractions of 8-9Gy. Primary end point was time to progression (TTP). Secondary endpoints were local control (LC), overall survival (OS), response rate (RR), toxicity, and quality of life (QoL). The calculated sample size was 100 patients., Results: Between May 2015 and April 2020, 30 patients were randomized to the study. Due to slow accrual the trial was closed prematurely. Two patients in the SBRT arm were considered ineligible leaving 16 patients in the TACE-DEB arm and 12 in the SBRT arm. Median follow-up was 28.1 months. Median TTP was 12 months for TACEDEB and 19 months for SBRT (p=0.15). Median LC was 12 months for TACE-DEB and >40 months (not reached) for SBRT (p=0.075). Median OS was 36.8 months for TACEDEB and 44.1 months for SBRT (p=0.36). A post-hoc analysis showed 100% for SBRT 1- and 2-year LC, and 54.4% and 43.6% for TACE-DEB (p=0.019). Both treatments resulted in RR>80%. Three episodes of possibly related toxicity grade ≥3 were observed after TACE-DEB. No episodes were observed after SBRT. QoL remained stable after both treatment arms., Conclusions: In this trial, TTP after TACE-DEB was not significantly improved by SBRT, while SBRT showed higher local antitumoral activity than TACE-DEB, without detrimental effects on OS, toxicity and QoL. To overcome poor accrual in randomized trials that include SBRT, and to generate evidence for including SBRT in treatment guidelines, international cooperation is needed., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2023
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27. Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC: the RALLY protocol.
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Andel D, Lam MGEH, de Bruijne J, Smits MLJ, Braat AJAT, Moelker A, Vegt E, Ruiter SJS, Noordzij W, Grazi G, Vallati GE, Bennink RJ, van Delden OM, Kranenburg OW, Ijzermans JNM, Nijkamp MW, Erdmann JI, Sciuto R, Hagendoorn J, and Borel Rinkes IHM
- Subjects
- Humans, Microspheres, Prospective Studies, Quality of Life, Hepatomegaly, Multicenter Studies as Topic, Carcinoma, Hepatocellular radiotherapy, Liver Neoplasms radiotherapy
- Abstract
Background: High dose unilobar radioembolization (also termed 'radiation lobectomy')-the transarterial unilobar infusion of radioactive microspheres as a means of controlling tumour growth while concomitantly inducing future liver remnant hypertrophy-has recently gained interest as induction strategy for surgical resection. Prospective studies on the safety and efficacy of the unilobar radioembolization-surgery treatment algorithm are lacking. The RALLY study aims to assess the safety and toxicity profile of holmium-166 unilobar radioembolization in patients with hepatocellular carcinoma ineligible for surgery due to insufficiency of the future liver remnant., Methods: The RALLY study is a multicenter, interventional, non-randomized, open-label, non-comparative safety study. Patients with hepatocellular carcinoma who are considered ineligible for surgery due to insufficiency of the future liver remnant (< 2.7%/min/m
2 on hepatobiliary iminodiacetic acid scan will be included. A classical 3 + 3 dose escalation model will be used, enrolling three to six patients in each cohort. The primary objective is to determine the maximum tolerated treated non-tumourous liver-absorbed dose (cohorts of 50, 60, 70 and 80 Gy). Secondary objectives are to evaluate dose-response relationships, to establish the safety and feasibility of surgical resection following unilobar radioembolization, to assess quality of life, and to generate a biobank., Discussion: This will be the first clinical study to assess the unilobar radioembolization-surgery treatment algorithm and may serve as a stepping stone towards its implementation in routine clinical practice., Trial Registration: Netherlands Trial Register NL8902 , registered on 2020-09-15., (© 2023. BioMed Central Ltd., part of Springer Nature.)- Published
- 2023
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28. Long-term efficacy of metal versus plastic stents in inoperable perihilar cholangiocarcinoma; a multicenter retrospective propensity score matched comparison.
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Fritzsche JA, de Jong DM, Borremans JJMM, Bruno MJ, Van Delden OM, Erdmann JI, Fockens P, de Gooyer PGM, Groot Koerkamp B, Klümpen HJ, Moelker A, Montazeri NSM, Nooijen LE, Ponsioen CY, Van Wanrooij RLJ, van Driel LMJW, and Voermans RP
- Subjects
- Humans, Retrospective Studies, Propensity Score, Stents, Metals, Plastics, Palliative Care methods, Treatment Outcome, Klatskin Tumor surgery, Bile Duct Neoplasms surgery, Bile Duct Neoplasms pathology, Cholangiocarcinoma
- Abstract
Background: For palliative drainage of inoperable perihilar cholangiocarcinoma (pCCA) uncovered metal stents are preferred over plastic stents. However, there is a lack of data on re-interventions at the long-term. The aim is to evaluate the potential difference in the number of re-interventions in patients surviving at least 6 months., Methods: Retrospective study including patients with pCCA who underwent plastic stent placement(s) or had metal stent(s) in situ for at least 6 months. The primary outcome was the number of re-interventions per patient-year. A propensity score matching (1:1) analysis was performed using age, Bismuth classification, reason for inoperability, pathological confirmation, systemic therapy and initial approach (endoscopic vs percutaneous)., Results: Patients in the metal stent group (n = 87) underwent fewer re-interventions compared with the plastic stent group (n = 40) (3.0 vs. 4.7 per patient-year; IRR, 0.64; 95% CI, 0.47 to 0.88). When only non-elective re-interventions were included, there was no significant difference (2.1 vs. 2.7; IRR, 0.76; 95% CI, 0.55 to 1.08). Results were similar in the propensity score-matched dataset., Conclusions: This study shows that, also in patients with inoperable pCCA who survive at least 6 months, placement of metal stent(s) leads to fewer re-interventions in comparison with plastic stents., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2023
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29. Intraoperative Ultrasound During Surgical Exploration in Patients with Pancreatic Cancer and Vascular Involvement (ULTRAPANC): A Prospective Multicenter Study.
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Michiels N, Doppenberg D, Groen JV, van Veldhuisen E, Bonsing BA, Busch OR, Crobach ASLP, van Delden OM, van Dieren S, Farina A, de Hingh IHJT, Hurks R, Nederend J, Shahbazi Feshtali S, Tank Y, Vahrmeijer AL, Wasser M, Besselink MG, and Mieog JSD
- Subjects
- Humans, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Prospective Studies, Neoadjuvant Therapy, Pancreatic Neoplasms, Pancreatic Neoplasms diagnostic imaging, Pancreatic Neoplasms surgery, Pancreatic Neoplasms drug therapy
- Abstract
Background: Determining the resectability of pancreatic cancer with vascular involvement on preoperative computed tomography imaging remains challenging, especially following preoperative chemotherapy and chemoradiotherapy. Intraoperative ultrasound (IOUS) may provide real-time additional information, but prospective multicenter series confirming its value are lacking., Patients and Methods: This prospective multicenter study included patients undergoing surgical exploration for pancreatic cancer with vascular involvement. All patients underwent IOUS at the start of explorative laparotomy. Primary outcomes were resectability status as defined by the National Comprehensive Cancer Network and the extent of vascular involvement., Results: Overall, 85 patients were included, of whom 74 (87%) were post preoperative chemotherapy, and mostly following FOLFIRINOX regimen (n = 57; 76%). On the basis of preoperative imaging, 34 (40%) patients were staged as resectable (RPC), 32 (38%) borderline resectable (BRPC), and 19 (22%) locally advanced pancreatic cancer (LAPC). IOUS changed the resectability status in 32/85 (38%) patients (p < 0.001), including 8/19 (42%) patients with LAPC who were downstaged (4 to BRPC, 4 to RPC), and 22/32 (69%) patients with BRPC who were downstaged to RPC. Among patients with presumed superior mesenteric artery (SMA) involvement, 20/28 (71%) had no SMA involvement on IOUS. In 15 of these 20 patients a pancreatic resection was performed, all with R0 SMA margin., Conclusion: IOUS during surgical exploration for pancreatic cancer and vascular involvement downstaged the resectability status in over one-third of patients, which could facilitate progress during surgical exploration. This finding should be confirmed by larger studies, including detailed pathology assessment. Trial Registration www.trialregister.nl (NL7621)., (© 2023. The Author(s).)
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- 2023
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30. Long-term follow-up of a randomized trial of biliary drainage in perihilar cholangiocarcinoma.
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Nooijen LE, Franssen S, Buis CI, Dejong CHC, den Dulk M, van Delden OM, Ijzermans JN, Groot Koerkamp B, Kazemier G, van Lienden K, Klümpen HJ, Kuipers H, Olij B, Porte RJ, Rauws EA, Voermans RP, van Gulik TM, Erdmann JI, Roos E, and Coelen RJ
- Subjects
- Humans, Follow-Up Studies, Drainage adverse effects, Bile Ducts, Intrahepatic surgery, Klatskin Tumor pathology, Bile Duct Neoplasms pathology, Cholangiocarcinoma surgery
- Abstract
Background and Aims: The DRAINAGE trial was a randomized controlled trial comparing preoperative endoscopic (EBD) and percutaneous biliary drainage (PTBD) in patients with potentially resectable, perihilar cholangiocarcinoma (pCCA). The aim of this study was to compare the long-term outcomes., Methods: Patients were randomized in four tertiary referral centers. Follow-up data were available for all included patients. Primary outcome was overall survival (OS). Secondary outcomes were readmissions, and re-interventions not including in-trial interventions., Results: A total of 54 patients were randomized; 27 in both groups. Median follow-up for both groups was 62 months (95% CI 54-70). The median OS was 13 months (95% CI 7.9-18.1) in the EBD and 7 months (95% CI 0.0-17.2) in the PTBD group (P = 0.28). Twenty (37%, n = 8 EBD vs n = 12 PTBD, P = 0.43) of 54 patients were readmitted at least once, mostly due to drainage-related complications (n = 13, 24%). Of note, 14 out of the 54 patients died within the trial. A total of 76 drainage procedures (32 EBD and 44 PTBD) were performed in 28 patients. The median number of stent or drain placements was 2 (2-4) for the EBD group and 2 (1-3) for the PTBD group (P = 0.77)., Discussion: Although this follow-up study represented a small cohort, no long-term differences in survival, readmissions, and drainage procedures for EBD and PTBD were found, even when comparing the resected and unresected group. However, this study demonstrates the complexity of biliary drainage for patients with potentially resectable pCCA, even in tertiary referral centers., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
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- 2023
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31. Study protocol for a multicentre nationwide prospective cohort study to investigate the natural course and clinical outcome in benign liver tumours and cysts in the Netherlands: the BELIVER study.
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Furumaya A, Haring MPD, van Rosmalen BV, Klompenhouwer AJ, Besselink MG, de Man RA, IJzermans JNM, Thomeer MGJ, Kramer M, Coolsen MME, Tushuizen ME, Schaapherder AF, de Haas RJ, Duiker EW, Kazemier G, van Delden OM, Verheij J, Takkenberg RB, Cuperus FJC, De Meijer VE, and Erdmann JI
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- Humans, Prospective Studies, Netherlands epidemiology, Cohort Studies, Observational Studies as Topic, Multicenter Studies as Topic, Adenoma, Liver Cell surgery, Liver Neoplasms surgery, Cysts
- Abstract
Introduction: Benign liver tumours and cysts (BLTCs) comprise a heterogeneous group of cystic and solid lesions, including hepatic haemangioma, focal nodular hyperplasia and hepatocellular adenoma. Some BLTCs, for example, (large) hepatocellular adenoma, are at risk of complications. Incidence of malignant degeneration or haemorrhage is low in most other BLTCs. Nevertheless, the diagnosis BLTC may carry a substantial burden and patients may be symptomatic, necessitating treatment. The indications for interventions remain matter of debate. The primary study aim is to investigate patient-reported outcomes (PROs) of patients with BLTCs, with special regards to the influence of invasive treatment as compared with the natural course of the disease., Methods and Analysis: A nationwide observational cohort study of patients with BLTC will be performed between October 2021 and October 2026, the minimal follow-up will be 2 years. During surveillance, a questionnaire regarding symptoms and their impact will be sent to participants on a biannual basis and more often in case of invasive intervention. The questionnaire was previously developed based on PROs considered relevant to patients with BLTCs and their caregivers. Most questionnaires will be administered by computerised adaptive testing through the Patient-Reported Outcomes Measurement Information System. Data, such as treatment outcomes, will be extracted from electronic patient files. Multivariable analysis will be performed to identify patient and tumour characteristics associated with significant improvement in PROs or a complicated postoperative course., Ethics and Dissemination: The study was assessed by the Medical Ethics Committee of the University Medical Center Groningen and the Amsterdam UMC. Local consultants will provide information and informed consent will be asked of all patients. Results will be published in a peer-reviewed journal., Study Registration: NL8231-10 December 2019; Netherlands Trial Register., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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32. Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy.
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Korenblik R, Olij B, Aldrighetti LA, Hilal MA, Ahle M, Arslan B, van Baardewijk LJ, Baclija I, Bent C, Bertrand CL, Björnsson B, de Boer MT, de Boer SW, Bokkers RPH, Rinkes IHMB, Breitenstein S, Bruijnen RCG, Bruners P, Büchler MW, Camacho JC, Cappelli A, Carling U, Chan BKY, Chang DH, Choi J, Font JC, Crawford M, Croagh D, Cugat E, Davis R, De Boo DW, De Cobelli F, De Wispelaere JF, van Delden OM, Delle M, Detry O, Díaz-Nieto R, Dili A, Erdmann JI, Fisher O, Fondevila C, Fretland Å, Borobia FG, Gelabert A, Gérard L, Giuliante F, Gobardhan PD, Gómez F, Grünberger T, Grünhagen DJ, Guitart J, Hagendoorn J, Heil J, Heise D, Herrero E, Hess GF, Hoffmann MH, Iezzi R, Imani F, Nguyen J, Jovine E, Kalff JC, Kazemier G, Kingham TP, Kleeff J, Kollmar O, Leclercq WKG, Ben SL, Lucidi V, MacDonald A, Madoff DC, Manekeller S, Martel G, Mehrabi A, Mehrzad H, Meijerink MR, Menon K, Metrakos P, Meyer C, Moelker A, Modi S, Montanari N, Navines J, Neumann UP, Peddu P, Primrose JN, Qu X, Raptis D, Ratti F, Ridouani F, Rogan C, Ronellenfitsch U, Ryan S, Sallemi C, Moragues JS, Sandström P, Sarriá L, Schnitzbauer A, Serenari M, Serrablo A, Smits MLJ, Sparrelid E, Spüntrup E, Stavrou GA, Sutcliffe RP, Tancredi I, Tasse JC, Udupa V, Valenti D, Fundora Y, Vogl TJ, Wang X, White SA, Wohlgemuth WA, Yu D, Zijlstra IAJ, Binkert CA, Bemelmans MHA, van der Leij C, Schadde E, and van Dam RM
- Subjects
- Accreditation, Hepatectomy methods, Hepatic Veins pathology, Hepatomegaly, Humans, Hypertrophy etiology, Hypertrophy pathology, Hypertrophy surgery, Liver surgery, Multicenter Studies as Topic, Portal Vein pathology, Prospective Studies, Treatment Outcome, Embolization, Therapeutic methods, Liver Neoplasms diagnostic imaging, Liver Neoplasms pathology, Liver Neoplasms therapy
- Abstract
Study Purpose: The DRAGON 1 trial aims to assess training, implementation, safety and feasibility of combined portal- and hepatic-vein embolization (PVE/HVE) to accelerate future liver remnant (FLR) hypertrophy in patients with borderline resectable colorectal cancer liver metastases., Methods: The DRAGON 1 trial is a worldwide multicenter prospective single arm trial. The primary endpoint is a composite of the safety of PVE/HVE, 90-day mortality, and one year accrual monitoring of each participating center. Secondary endpoints include: feasibility of resection, the used PVE and HVE techniques, FLR-hypertrophy, liver function (subset of centers), overall survival, and disease-free survival. All complications after the PVE/HVE procedure are documented. Liver volumes will be measured at week 1 and if applicable at week 3 and 6 after PVE/HVE and follow-up visits will be held at 1, 3, 6, and 12 months after the resection., Results: Not applicable., Conclusion: DRAGON 1 is a prospective trial to assess the safety and feasibility of PVE/HVE. Participating study centers will be trained, and procedures standardized using Work Instructions (WI) to prepare for the DRAGON 2 randomized controlled trial. Outcomes should reveal the accrual potential of centers, safety profile of combined PVE/HVE and the effect of FLR-hypertrophy induction by PVE/HVE in patients with CRLM and a small FLR., Trial Registration: Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019)., (© 2022. The Author(s).)
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- 2022
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33. Study Protocol: Adjuvant Holmium-166 Radioembolization After Radiofrequency Ablation in Early-Stage Hepatocellular Carcinoma Patients-A Dose-Finding Study (HORA EST HCC Trial).
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Hendriks P, Rietbergen DDD, van Erkel AR, Coenraad MJ, Arntz MJ, Bennink RJ, Braat AE, Crobach ASLP, van Delden OM, van der Hulle T, Klümpen HJ, van der Meer RW, Nijsen JFW, van Rijswijk CSP, Roosen J, Ruijter BN, Smit F, Stam MK, Takkenberg RB, Tushuizen ME, van Velden FHP, de Geus-Oei LF, and Burgmans MC
- Subjects
- Holmium, Humans, Prospective Studies, Radioisotopes, Retrospective Studies, Tissue Distribution, Treatment Outcome, Carcinoma, Hepatocellular diagnostic imaging, Carcinoma, Hepatocellular surgery, Catheter Ablation, Embolization, Therapeutic methods, Liver Neoplasms diagnostic imaging, Liver Neoplasms drug therapy, Liver Neoplasms surgery, Radiofrequency Ablation
- Abstract
Purpose: To investigate the biodistribution of holmium-166 microspheres (
166 Ho-MS) when administered after radiofrequency ablation (RFA) of early-stage hepatocellular carcinoma (HCC). The aim is to establish a perfused liver administration dose that results in a tumoricidal dose of holmium-166 on the hyperaemic zone around the ablation necrosis (i.e. target volume)., Materials and Methods: This is a multicentre, prospective, dose-escalation study in HCC patients with a solitary lesion 2-5 cm, or a maximum of 3 lesions of ≤ 3 cm each. The day after RFA patients undergo angiography and cone-beam CT (CBCT) with (super)selective infusion of technetium-99 m labelled microalbumin aggregates (99m Tc-MAA). The perfused liver volume is segmented from the CBCT and166 Ho-MS is administered to this treatment volume 5-10 days later. The dose of holmium-166 is escalated in a maximum of 3 patient cohorts (60 Gy, 90 Gy and 120 Gy) until the endpoint is reached. SPECT/CT is used to determine the biodistribution of holmium-166. The endpoint is met when a dose of ≥ 120 Gy has been reached on the target volume in 9/10 patients of a cohort. Secondary endpoints include toxicity, local recurrence, disease-free and overall survival., Discussion: This study aims to find the optimal administration dose of adjuvant radioembolization with166 Ho-MS after RFA. Ultimately, the goal is to bring the efficacy of thermal ablation up to par with surgical resection for early-stage HCC patients., Trial Registration: Clinicaltrials.gov identifier: NCT03437382., (© 2022. The Author(s).)- Published
- 2022
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34. Outcomes of Irreversible Electroporation for Perihilar Cholangiocarcinoma: A Prospective Pilot Study.
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Franken LC, van Veldhuisen E, Ruarus AH, Coelen RJS, Roos E, van Delden OM, Besselink MG, Klümpen HJ, van Lienden KP, van Gulik TM, Meijerink MR, and Erdmann JI
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- Aged, Bile Ducts, Intrahepatic, Humans, Middle Aged, Pilot Projects, Prospective Studies, Survival Rate, Treatment Outcome, Bile Duct Neoplasms therapy, Electroporation methods, Klatskin Tumor therapy
- Abstract
Purpose: To investigate the safety and efficacy of percutaneous or open irreversible electroporation (IRE) in a prospective cohort of patients with locally advanced, unresectable perihilar cholangiocarcinoma (PHC)., Materials and Methods: In a multicenter Phase I/II study, patients with unresectable PHC due to extensive vascular involvement or N2 lymph node metastases or local recurrence after resection for PHC were included and treated by open or percutaneous IRE combined with palliative chemotherapy (current standard of care). The primary outcome was the number of major adverse events occurring within 90 d after IRE (grade ≥3), and the upper limit was predefined at 60%. Secondary outcomes included technical success rate, hospital stay, and overall survival (OS)., Results: Twelve patients (mean age, 63 y ± 12) were treated with IRE. The major adverse event rate was 50% (6 of 12 patients), and no 90-d mortality was observed. All procedures were technically successful, with no intraprocedural adverse events requiring additional interventions. The median OS from diagnosis was 21 mos (95% confidence interval, 15-27 mos), with a 1-y survival rate of 75% after IRE., Conclusions: Percutaneous IRE in selected patients with locally advanced PHC seems feasible, with a major adverse event rate of 50%, which was below the predefined upper safety limit in this prospective study. Future comparative research exploring the efficacy of IRE is warranted., (Copyright © 2022 SIR. Published by Elsevier Inc. All rights reserved.)
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- 2022
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35. A phase Ib/II study of regorafenib and paclitaxel in patients with beyond first-line advanced esophagogastric carcinoma (REPEAT).
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Stroes CI, Schokker S, Khurshed M, van der Woude SO, Mathôt RA, Slingerland M, de Vos-Geelen J, Zucchetti M, Matteo C, van Dijk E, Ylstra B, Thijssen V, Derks S, Godefa T, Dijksterhuis W, Breimer GE, van Delden OM, Verhoeven RH, Meijer SL, Bijlsma MF, and van Laarhoven HW
- Abstract
Purpose: Regorafenib monotherapy, a multikinase inhibitor of angiogenesis, tumor microenvironment, and tumorigenesis, showed promising results in gastric cancer. We aimed to assess the tolerability of regorafenib and paclitaxel in patients with advanced esophagogastric cancer (EGC) refractory to first-line treatment, and explore potential biomarkers., Methods: Patients received paclitaxel (80 mg/m
2 ) on days 1, 8, and 15 of a 28-day cycle and regorafenib (80/120/160 mg) on days 1-21 in the dose-escalation cohort, and the maximum-tolerated dose (MTD) in the dose-expansion cohort. Exploratory, overall survival (OS) and progression-free survival (PFS) were compared to a propensity-score matched cohort receiving standard second-/third-line systemic treatment. Paclitaxel pharmacokinetics were assessed using samples from day 1 (D1) and day 15 (D15). We performed enzyme-linked immunosorbent assay measurements of galectin-1, RNA sequencing, and shallow whole-genome sequencing of metastatic tumor biopsies for biomarker analyses., Results: In the dose-escalation cohort ( n = 14), the MTD of regorafenib was 120 mg. In all, 34 patients were enrolled in the dose-expansion cohort. Most common toxicities (all grades; grade ⩾ 3) were fatigue (79%; 4%) and sensory neuropathy (63%; 4%). Best responses achieved were partial response (28%) and stable disease (54%). Median OS and PFS were 7.8 and 4.2 months, respectively (median follow-up: 7.8 months). OS ( p = 0.08) and PFS ( p = 0.81) were not significantly improved compared to the matched cohort. Paclitaxel concentrations were significantly increased with regorafenib (D15) compared with paclitaxel only (D1; p < 0.05); no associations were observed with toxicity or efficacy. An increase in circulating galectin-1 compared to baseline was associated with shorter OS ( p < 0.01). Enrichment of angiogenesis-related gene expression was observed in short survivors measured by RNA sequencing. Chromosome 19q13.12-q13.2 amplification was associated with shorter OS ( p = 0.02) and PFS ( p = 0.02)., Conclusion: Treatment with regorafenib and paclitaxel is tolerable and shows promising efficacy in advanced EGC refractory to first-line treatment. Galectin-1 and chromosome 19q13.12-q13.2 amplification could serve as negative predictive biomarkers for treatment response., Registration: Clinicaltrials.gov, NCT02406170, https://clinicaltrials.gov/ct2/show/NCT02406170., Competing Interests: Conflict of interest statement: All authors completed the disclosure of conflict of interest. The following authors declared a potential conflict of interest: S. Schokker has received travel and accommodation reimbursement from Roche. R.A.A. Mathôt has received grants from NOW, ZonMW, and unrestricted investigator research grants from Baxter, Baxalta, Shire, Takeda, Bayer, CSL Behring and Sobi, and reports and advisory role for Bayer, CSL Behring, Merck Sharp & Dohme, Baxter, Baxalta, Shire and Takeda, with fees paid to the institution. R.H.A. Verhoeven has received research grants from Roche and BMS. M.F. Bijlsma reports an advisory role for Servier, and has received a research grant from Celgene. M.I. van Berge Henegouwen reports unrestricted research grants from Stryker and Olympus with fees paid to the institution, and an advisory role for Johnson and Johnson, Mylan, and Medtronic, with fees paid to the institution. H.W.M. van Laarhoven reports an advisory role for BMS, Celgene, Lilly, Merck, Nordic, and Servier, and has received unrestricted research funding from Bayer, BMS, Celgene, Lilly, Merck Serono, MSD, Nordic, Philips, Roche and Servier, with fees paid to the institution., (© The Author(s), 2022.)- Published
- 2022
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36. Algorithm-based care versus usual care for the early recognition and management of complications after pancreatic resection in the Netherlands: an open-label, nationwide, stepped-wedge cluster-randomised trial.
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Smits FJ, Henry AC, Besselink MG, Busch OR, van Eijck CH, Arntz M, Bollen TL, van Delden OM, van den Heuvel D, van der Leij C, van Lienden KP, Moelker A, Bonsing BA, Borel Rinkes IH, Bosscha K, van Dam RM, Derksen WJM, den Dulk M, Festen S, Groot Koerkamp B, de Haas RJ, Hagendoorn J, van der Harst E, de Hingh IH, Kazemier G, van der Kolk M, Liem M, Lips DJ, Luyer MD, de Meijer VE, Mieog JS, Nieuwenhuijs VB, Patijn GA, Te Riele WW, Roos D, Schreinemakers JM, Stommel MWJ, Wit F, Zonderhuis BA, Daamen LA, van Werkhoven CH, Molenaar IQ, and van Santvoort HC
- Subjects
- Algorithms, Hemorrhage, Humans, Netherlands epidemiology, Postoperative Complications epidemiology, Postoperative Complications therapy, Treatment Outcome, Drainage, Pancreatectomy adverse effects
- Abstract
Background: Early recognition and management of postoperative complications, before they become clinically relevant, can improve postoperative outcomes for patients, especially for high-risk procedures such as pancreatic resection., Methods: We did an open-label, nationwide, stepped-wedge cluster-randomised trial that included all patients having pancreatic resection during a 22-month period in the Netherlands. In this trial design, all 17 centres that did pancreatic surgery were randomly allocated for the timing of the crossover from usual care (the control group) to treatment given in accordance with a multimodal, multidisciplinary algorithm for the early recognition and minimally invasive management of postoperative complications (the intervention group). Randomisation was done by an independent statistician using a computer-generated scheme, stratified to ensure that low-medium-volume centres alternated with high-volume centres. Patients and investigators were not masked to treatment. A smartphone app was designed that incorporated the algorithm and included the daily evaluation of clinical and biochemical markers. The algorithm determined when to do abdominal CT, radiological drainage, start antibiotic treatment, and remove abdominal drains. After crossover, clinicians were trained in how to use the algorithm during a 4-week wash-in period; analyses comparing outcomes between the control group and the intervention group included all patients other than those having pancreatic resection during this wash-in period. The primary outcome was a composite of bleeding that required invasive intervention, organ failure, and 90-day mortality, and was assessed by a masked adjudication committee. This trial was registered in the Netherlands Trial Register, NL6671., Findings: From Jan 8, 2018, to Nov 9, 2019, all 1805 patients who had pancreatic resection in the Netherlands were eligible for and included in this study. 57 patients who underwent resection during the wash-in phase were excluded from the primary analysis. 1748 patients (885 receiving usual care and 863 receiving algorithm-centred care) were included. The primary outcome occurred in fewer patients in the algorithm-centred care group than in the usual care group (73 [8%] of 863 patients vs 124 [14%] of 885 patients; adjusted risk ratio [RR] 0·48, 95% CI 0·38-0·61; p<0·0001). Among patients treated according to the algorithm, compared with patients who received usual care there was a decrease in bleeding that required intervention (47 [5%] patients vs 51 [6%] patients; RR 0·65, 0·42-0·99; p=0·046), organ failure (39 [5%] patients vs 92 [10%] patients; 0·35, 0·20-0·60; p=0·0001), and 90-day mortality (23 [3%] patients vs 44 [5%] patients; 0·42, 0·19-0·92; p=0·029)., Interpretation: The algorithm for the early recognition and minimally invasive management of complications after pancreatic resection considerably improved clinical outcomes compared with usual care. This difference included an approximate 50% reduction in mortality at 90 days., Funding: The Dutch Cancer Society and UMC Utrecht., Competing Interests: Declaration of interests CvdL is the Secretary of the Dutch Society of Interventional Radiology (unpaid position). CHvW's institution received payments from Pfizer, Biomerieux, Da Volterra, and MSD and he has a European Patent Application with Da Volterrra, University Antwerp, and University Medical Centre Utrecht Holdings. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)
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- 2022
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37. Study Protocol PROMETHEUS: Prospective Multicenter Study to Evaluate the Correlation Between Safety Margin and Local Recurrence After Thermal Ablation Using Image Co-registration in Patients with Hepatocellular Carcinoma.
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Oosterveer TTM, van Erp GCM, Hendriks P, Broersen A, Overduin CG, van Rijswijk CSP, van Erkel AR, van der Meer RW, Tushuizen ME, Moelker A, Meijerink MR, van Delden OM, de Jong KP, van der Leij C, Smits MLJ, Urlings TAJ, Braak JPBM, Meershoek-Klein Kranenbarg E, van Duijn-de Vreugd B, Zeijdner E, Goeman JJ, Fütterer JJ, Coenraad MJ, Dijkstra J, and Burgmans MC
- Subjects
- Humans, Margins of Excision, Multicenter Studies as Topic, Neoplasm Recurrence, Local surgery, Prospective Studies, Treatment Outcome, Carcinoma, Hepatocellular diagnostic imaging, Carcinoma, Hepatocellular pathology, Carcinoma, Hepatocellular surgery, Catheter Ablation adverse effects, Catheter Ablation methods, Liver Neoplasms diagnostic imaging, Liver Neoplasms pathology, Liver Neoplasms surgery
- Abstract
Purpose: The primary objective is to determine the minimal ablation margin required to achieve a local recurrence rate of < 10% in patients with hepatocellular carcinoma undergoing thermal ablation. Secondary objectives are to analyze the correlation between ablation margins and local recurrence and to assess efficacy., Materials and Methods: This study is a prospective, multicenter, non-experimental, non-comparative, open-label study. Patients > 18 years with Barcelona Clinic Liver Cancer stage 0/A hepatocellular carcinoma (or B with a maximum of two lesions < 5 cm each) are eligible. Patients will undergo dual-phase contrast-enhanced computed tomography directly before and after ablation. Ablation margins will be quantitatively assessed using co-registration software, blinding assessors (i.e. two experienced radiologists) for outcome. Presence and location of recurrence are evaluated independently on follow-up scans by two other experienced radiologists, blinded for the quantitative margin analysis. A sample size of 189 tumors (~ 145 patients) is required to show with 80% power that the risk of local recurrence is confidently below 10%. A two-sided binomial z-test will be used to test the null hypothesis that the local recurrence rate is ≥ 10% for patients with a minimal ablation margin ≥ 2 mm. Logistic regression will be used to find the relationship between minimal ablation margins and local recurrence. Kaplan-Meier estimates are used to assess local and overall recurrence, disease-free and overall survival., Discussion: It is expected that this study will result in a clear understanding of the correlation between ablation margins and local recurrence. Using co-registration software in future patients undergoing ablation for hepatocellular carcinoma may improve intraprocedural evaluation of technical success. Trial registration The Netherlands Trial Register (NL9713), https://www.trialregister.nl/trial/9713 ., (© 2022. The Author(s).)
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- 2022
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38. Biliopancreatic and biliary leak after pancreatoduodenectomy treated by percutaneous transhepatic biliary drainage.
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Henry AC, Smits FJ, van Lienden K, van den Heuvel DAF, Hofman L, Busch OR, van Delden OM, Zijlstra IA, Schreuder SM, Lamers AB, van Leersum M, van Strijen MJL, Vos JA, Te Riele WW, Molenaar IQ, Besselink MG, and van Santvoort HC
- Subjects
- Drainage adverse effects, Humans, Pancreaticoduodenectomy adverse effects, Retrospective Studies, Biliary Tract Diseases therapy, Biliary Tract Surgical Procedures adverse effects
- Abstract
Background: Complementary to percutaneous intra-abdominal drainage, percutaneous transhepatic biliary drainage (PTBD) might ameliorate healing of pancreatic fistula and biliary leakage after pancreatoduodenectomy by diversion of bile from the site of leakage. This study evaluated technical and clinical outcomes of PTBD for this indication., Methods: All patients undergoing PTBD for leakage after pancreatoduodenectomy were retrospectively evaluated in two tertiary pancreatic centers (2014-2019). Technical success was defined as external biliary drainage. Clinical success was defined as discharge with a resolved leak, without additional surgical interventions for anastomotic leakage other than percutaneous intra-abdominal drainage., Results: Following 822 pancreatoduodenectomies, 65 patients (8%) underwent PTBD. Indications were leakage of the pancreaticojejunostomy (n = 25; 38%), hepaticojejunostomy (n = 15; 23%) and of both (n = 25; 38%). PTBD was technically successful in 64 patients (98%) with drain revision in 40 patients (63%). Clinical success occurred in 60 patients (94%). Leakage resolved after median 33 days (IQR 21-60). PTBD related complications occurred in 23 patients (35%), including cholangitis (n = 14; 21%), hemobilia (n = 7; 11%) and PTBD related bleeding requiring re-intervention (n = 4; 6%). In hospital mortality was 3% (n = 2)., Conclusion: Although drain revisions and complications are common, PTBD is highly feasible and appears to be effective in the treatment of biliopancreatic leakage after pancreatoduodenectomy., (Copyright © 2021 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.)
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- 2022
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39. Survival Benefit of Repeat Local Treatment in Patients Suffering From Early Recurrence of Colorectal Cancer Liver Metastases.
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Hellingman T, Kuiper BI, Buffart LM, Meijerink MR, Versteeg KS, Swijnenburg RJ, van Delden OM, Haasbeek CJA, de Vries JJJ, van Waesberghe JHTM, Zonderhuis BM, van der Vliet HJ, and Kazemier G
- Subjects
- Hepatectomy, Humans, Neoplasm Recurrence, Local therapy, Retrospective Studies, Colorectal Neoplasms surgery, Liver Neoplasms drug therapy, Liver Neoplasms surgery
- Abstract
Background: A uniform treatment strategy for patients suffering from early recurrence after local treatment of CRLM is currently lacking. The aim of this observational cohort study was to assess the potential survival benefit of repeat local treatment compared to systemic therapy in patients suffering from early recurrence of CRLM., Patients and Methods: Patients who developed recurrent CRLM within 12 months after initial local treatment with curative intent were retrospectively identified in Amsterdam University Medical Centers between 2009-2019. Differences in overall and progression-free survival among treatment strategies were assessed using multivariable Cox regression analyses., Results: A total of 135 patients were included. Median overall survival of 41 months [range 4-135] was observed in patients who received repeat local treatment, consisting of upfront or repeat local treatment after neoadjuvant systemic therapy, compared to 24 months [range 1-55] in patients subjected to systemic therapy alone (adjusted HR = 0.42 [95%-CI: 0.25-0.72]; P = .002). Prolonged progression-free survival was observed after neoadjuvant systemic therapy followed by repeat local treatment, as compared to upfront repeat local treatment in patients with recurrent CRLM within 4 months following initial local treatment of CRLM (adjusted HR = 0.36 [95%-CI: 0.15-0.86]; P = .021)., Conclusion: Patients with early recurrence of CRLM should be considered for repeat local treatment strategies. A multimodality approach, consisting of neoadjuvant systemic therapy followed by repeat local treatment, appeared favorable in patients with recurrence within 4 months following initial local treatment of CRLM., (Copyright © 2021. Published by Elsevier Inc.)
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- 2021
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40. Liver function after combined selective internal radiation therapy or sorafenib monotherapy in advanced hepatocellular carcinoma.
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Ricke J, Schinner R, Seidensticker M, Gasbarrini A, van Delden OM, Amthauer H, Peynircioglu B, Bargellini I, Iezzi R, De Toni EN, Malfertheiner P, Pech M, and Sangro B
- Subjects
- Aged, Carcinoma, Hepatocellular epidemiology, Carcinoma, Hepatocellular physiopathology, Female, Humans, Liver Function Tests methods, Liver Function Tests statistics & numerical data, Liver Neoplasms drug therapy, Liver Neoplasms epidemiology, Liver Neoplasms physiopathology, Male, Middle Aged, Prospective Studies, Radiotherapy methods, Radiotherapy statistics & numerical data, Sorafenib therapeutic use, Spain epidemiology, Treatment Outcome, Carcinoma, Hepatocellular drug therapy, Radiotherapy standards, Sorafenib pharmacology
- Abstract
Background & Aims: SORAMIC is a previously published randomised controlled trial assessing survival in patients with advanced hepatocellular carcinoma who received sorafenib with or without selective internal radiation therapy (SIRT). Based on the per-protocol (PP) population, we assessed whether the outcome of patients receiving SIRT+sorafenib vs. sorafenib alone was affected by adverse effects of SIRT on liver function., Methods: The PP population consisted of 109 (SIRT+sorafenib) vs. 173 patients (sorafenib alone). Comparisons were made between subgroups who achieved a significant survival benefit or trend towards improved survival with SIRT and the inverse group without a survival benefit: <65 years-old vs. ≥65 years-old, Child-Pugh 5 vs. 6, no transarterial chemoembolisation (TACE) vs. prior TACE, no cirrhosis vs. cirrhosis, non-alcohol- vs. alcohol-related aetiology. The albumin-bilirubin (ALBI) score was used to monitor liver function over time during follow-up., Results: ALBI scores increased in all patient groups during follow-up. In the PP population, ALBI score increases were higher in the SIRT+sorafenib than the sorafenib arm (p = 0.0021 month 4, p <0.0001 from month 6). SIRT+sorafenib conferred a survival benefit compared to sorafenib alone in patients aged <65 years-old, those without cirrhosis, those with Child-Pugh 5, and those who had not received TACE. A higher increase in ALBI score was observed in the inverse subgroups in whom survival was not improved by adding SIRT (age ≥65 years-old, p <0.05; cirrhosis, p = 0.07; Child-Pugh 6, p <0.05; prior TACE, p = 0.08)., Conclusion: SIRT frequently has a negative, often subclinical, effect on liver function in patients with hepatocellular carcinoma, which may impair prognosis after treatment. Careful patient selection for SIRT as well as prevention of clinical and subclinical liver damage by selective treatments, high tumour uptake ratio, and medical prophylaxis could translate into better efficacy., Clinical Trial Number: EudraCT 2009-012576-27, NCT01126645 LAY SUMMARY: This study of treatments in patients with hepatocellular carcinoma found that selective internal radiation therapy (SIRT) has an adverse effect on liver function that may affect patient outcomes. Patients should be carefully selected before they undergo SIRT and the treatment technique should be optimised for maximum protection of non-target liver parenchyma., Competing Interests: Conflict of interest Dr. Ricke reports grants from Sirtex Medical and Bayer AG, during the conduct of the study; personal fees from Sirtex Medical, Bayer, Boston Scientific, Bristol-Myers Squibb, EISAI, LaForce, Roche, Lilly Deutschland GmbH, Siemens Healthineers, Medison Pharma, MCI Deutschland, and LIAM GmbH, outside the submitted work. Dr. Schinner nothing to disclose. Dr. Seidensticker reports grants from Sirtex Medical and Bayer AG, during the conduct of the study; personal fees from Sirtex Medical, Bayer, and LIAM GmbH, outside the submitted work. Dr. Gasbarrini nothing to disclose. Dr. van Delden nothing to disclose. Dr. Amthauer reports grants from Sirtex Medical and Bayer AG, during the conduct of the study; lecture and/or personal fees from Sirtex Medical, Pfizer, Terumo, EISAI, GE, Novartis and Norgine, outside the submitted work. Dr. Peynircioglu reports personal fees from Bayer, Sirtex Medical, and Boston Scientific outside the submitted work. Dr. Bargellini reports personal fees from Sirtex Medical, Terumo, Boston Scientific, BTG, EISAI, Bayer, Guerbet, and GE Healthcare, outside the submitted work. Dr. Iezzi nothing to disclose. Dr. De Toni has served as a paid consultant for AstraZeneca, Bayer, BMS, EISAI, Eli Lilly & Co, Pfizer, IPSEN, Terumo, and Roche. He has received reimbursement of meeting attendance fees and travel expenses from Arqule, AstraZeneca, BMS, Bayer, Celsion, and Roche, and lecture honoraria from BMS and Falk. He has received third-party funding for scientific research from Arqule, AstraZeneca, BMS, Bayer, Eli Lilly, IPSEN, and Roche. Dr Malfertheiner reports grants from Bayer and Sirtex, during the conduct of the study, as well as personal fees from Aboca, Alfasigma, Bayer Healthcare, Danone, Malesci, and Menarini. Dr. Pech reports grants from Bayer Healthcare, grants and personal fees from Sirtex. Dr. Sangro reports consulting or advisory activities with Adaptimmune, AstraZeneca, Bayer, BMS, Boston Scientific/BTG, Eisai, Eli-Lilly, Ipsen, Onxeo, Roche, and Sirtex; speaker activities with AstraZeneca, Bayer, BMS, Ipsen, Lilly, Roche, and Sirtex; research grants (to institution) with BMS and Sirtex. Please refer to the accompanying ICMJE disclosure forms for further details., (Copyright © 2021 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)
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- 2021
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41. Assessment of Imaging Modalities Against Liver Biopsy in Nonalcoholic Fatty Liver Disease: The Amsterdam NAFLD-NASH Cohort.
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Troelstra MA, Witjes JJ, van Dijk AM, Mak AL, Gurney-Champion O, Runge JH, Zwirs D, Stols-Gonçalves D, Zwinderman AH, Ten Wolde M, Monajemi H, Ramsoekh S, Sinkus R, van Delden OM, Beuers UH, Verheij J, Nieuwdorp M, Nederveen AJ, and Holleboom AG
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- Biopsy, Humans, Liver diagnostic imaging, Magnetic Resonance Imaging, Prospective Studies, Elasticity Imaging Techniques, Non-alcoholic Fatty Liver Disease diagnostic imaging
- Abstract
Background: Noninvasive diagnostic methods are urgently required in disease stratification and monitoring in nonalcoholic fatty liver disease (NAFLD). Multiparametric magnetic resonance imaging (MRI) is a promising technique to assess hepatic steatosis, inflammation, and fibrosis, potentially enabling noninvasive identification of individuals with active and advanced stages of NAFLD., Purpose: To examine the diagnostic performance of multiparametric MRI for the assessment of disease severity along the NAFLD disease spectrum with comparison to histological scores., Study Type: Prospective, cohort., Population: Thirty-seven patients with NAFLD., Field Strength/sequence: Multiparametric MRI at 3.0 T consisted of magnetic resonance (MR) spectroscopy (MRS) with multi-echo stimulated-echo acquisition mode, magnitude-based and three-point Dixon using a two-dimensional multi-echo gradient echo, MR elastography (MRE) using a generalized multishot gradient-recalled echo sequence and intravoxel incoherent motion (IVIM) using a multislice diffusion weighted single-shot echo-planar sequence., Assessment: Histological steatosis grades were compared to proton density fat fraction measured by MRS (PDFF
MRS ), magnitude-based MRI (PDFFMRI-M ), and three-point Dixon (PDFFDixon ), as well as FibroScan® controlled attenuation parameter (CAP). Fibrosis and disease activity were compared to IVIM and MRE. FibroScan® liver stiffness measurements were compared to fibrosis levels. Diagnostic performance of all imaging parameters was determined for distinction between simple steatosis and nonalcoholic steatohepatitis (NASH)., Statistical Tests: Spearman's rank test, Kruskal-Wallis test, Dunn's post-hoc test with Holm-Bonferroni P-value adjustment, receiver operating characteristic curve analysis. A P-value <0.05 was considered statistically significant., Results: Histological steatosis grade correlated significantly with PDFFMRS (rs = 0.66, P < 0.001), PDFFMRI-M (rs = 0.68, P < 0.001), and PDFFDixon (rs = 0.67, P < 0.001), whereas no correlation was found with CAP. MRE and IVIM diffusion and perfusion significantly correlated with disease activity (rs = 0.55, P < 0.001, rs = -0.40, P = 0.016, rs = -0.37, P = 0.027, respectively) and fibrosis (rs = 0.55, P < 0.001, rs = -0.46, P = 0.0051; rs = -0.53, P < 0.001, respectively). MRE and IVIM diffusion had the highest area-under-the-curve for distinction between simple steatosis and NASH (0.79 and 0.73, respectively)., Data Conclusion: Multiparametric MRI is a promising method for noninvasive, accurate, and sensitive distinction between simple hepatic steatosis and NASH, as well as for the assessment of steatosis and fibrosis severity., Level of Evidence: 2 TECHNICAL EFFICACY: 2., (© 2021 The Authors. Journal of Magnetic Resonance Imaging published by Wiley Periodicals LLC. on behalf of International Society for Magnetic Resonance in Medicine.)- Published
- 2021
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42. Percutaneous Versus Surgical Interventions for Hepatic Cystic Echinococcosis: A Systematic Review and Meta-Analysis.
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Mönnink GLE, Stijnis C, van Delden OM, Spijker R, and Grobusch MP
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- Humans, Neoplasm Recurrence, Local, Prospective Studies, Echinococcosis, Echinococcosis, Hepatic diagnostic imaging, Echinococcosis, Hepatic surgery
- Abstract
Purpose: This systematic review and meta-analysis summarises the current literature on invasive treatment options of cystic hepatic echinococcosis (CE), comparing percutaneous radiological interventions to surgery, still the cornerstone of treatment in many countries., Methods: A literature search was conducted in Medline and EMBASE databases (PROSPERO registration number: CRD42019126150). The primary outcome was recurrence of cysts after treatment. Secondary outcomes were complications, duration of hospitalisation, mortality and treatment conversion., Results: The number of eligible prospective studies, in particular RCTs, was limited. In the four included studies, only conventional surgery is compared directly to percutaneous techniques. From the available data, in terms of recurrence, percutaneous treatment of hydatid cysts is non-inferior to open surgery. With regard to complications and length of hospital stay, outcomes favour percutaneous therapy., Conclusion: Although evidence from prospective research is small, percutaneous treatment in CE is an effective, safe and less invasive alternative to surgery., (© 2021. The Author(s).)
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- 2021
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43. Thermal ablation combined with transarterial chemoembolization for hepatocellular carcinoma: What is the right treatment sequence?
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Hendriks P, Sudiono DR, Schaapman JJ, Coenraad MJ, Tushuizen ME, Takkenberg RB, Oosterveer TTM, de Geus-Oei LF, van Delden OM, and Burgmans MC
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- Adult, Aged, Aged, 80 and over, Combined Modality Therapy, Humans, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Carcinoma, Hepatocellular diagnostic imaging, Carcinoma, Hepatocellular therapy, Catheter Ablation, Chemoembolization, Therapeutic, Liver Neoplasms diagnostic imaging, Liver Neoplasms therapy
- Abstract
Background: The combination treatment regimen of thermal ablation (TA) and transarterial chemoembolization (TACE) has gained a place in treatment of hepatocellular carcinoma (HCC) lesions > 3 cm unsuitable for surgery. Despite a high heterogeneity in the currently used treatment protocols, the pooled results of combined treatments seem to outperform those of TA or TACE alone. TACE preceding TA has been studied extensively, while results of the reverse treatment sequence are lacking. In this retrospective cohort study we compared the two treatment sequences., Patients and Methods: 38 patients (median age: 68.5 yrs (range 40-84), male: 34, liver cirrhosis: 33, early stage HCC: 21, intermediate stage HCC: 17) were included in two tertiary referral centers, of whom 27 were treated with TA and adjuvant TACE (TA + TACE). The other 11 patients received TA with neoadjuvant TACE (TACE + TA). Overall survival (OS), time to progression (TTP) and local tumor progression (LTP) free survival were determined for the entire cohort and compared between the two treatment sequences., Results: The median OS of all patients was 52.7 months and the median time to LTP was 11.5 months (censored for liver transplantation). No differences were found with respect to OS between the two treatment sequences. Median time to LTP for TACE + TA was 23.6 months and 8.1 months for TA + TACE (p = 0.19)., Discussion: No statistical differences were found for OS, TTP and time to LTP between patients treated with TA combined with neoadjuvant or adjuvant TACE., (Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.)
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- 2021
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44. Liver Decompensation as Late Complication in HCC Patients with Long-Term Response following Selective Internal Radiation Therapy.
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van Doorn DJ, Hendriks P, Burgmans MC, Rietbergen DDD, Coenraad MJ, van Delden OM, Bennink RJ, Labeur TA, Klümpen HJ, Eskens FALM, Moelker A, Vegt E, Sprengers D, Mostafavi N, Ijzermans J, and Takkenberg RB
- Abstract
Selective internal radiation therapy (SIRT) is used as a treatment for hepatocellular carcinoma (HCC). The aim of this study was to assess long-term liver-related complications of SIRT in patients who had not developed radioembolization-induced liver disease (REILD). The primary outcome was the percentage of patients without REILD that developed Child-Pugh (CP) ≥ B7 liver decompensation after SIRT. The secondary outcomes were overall survival (OS) and tumor response. These data were compared with a matched cohort of patients treated with sorafenib. Eighty-five patients were included, of whom 16 developed REILD. Of the remaining 69 patients, 38 developed liver decompensation CP ≥ B7. The median OS was 18 months. In patients without REILD, the median OS in patients with CP ≥ B7 was significantly shorter compared to those without CP ≥ B7; 16 vs. 31 months. In the case-matched analysis, the median OS was significantly longer in SIRT-treated patients; 16 vs. 8 months in sorafenib. Liver decompensation CP ≥ B7 occurred significantly more in SIRT when compared to sorafenib; 62% vs. 27%. The ALBI score was an independent predictor of liver decompensation (OR 0.07) and OS (HR 2.83). After SIRT, liver decompensation CP ≥ B7 often developed as a late complication in HCC patients and was associated with a shorter OS. The ALBI score was predictive of CP ≥ B7 liver decompensation and the OS, and this may be a valuable marker for patient selection for SIRT.
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- 2021
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45. Predictive Factors for Hypertrophy of the Future Liver Remnant After Portal Vein Embolization: A Systematic Review.
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Soykan EA, Aarts BM, Lopez-Yurda M, Kuhlmann KFD, Erdmann JI, Kok N, van Lienden KP, Wilthagen EA, Beets-Tan RGH, van Delden OM, Gomez FM, and Klompenhouwer EG
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- Embolization, Therapeutic, Hepatectomy, Humans, Liver diagnostic imaging, Liver Neoplasms surgery, Liver Neoplasms therapy, Portal Vein diagnostic imaging, Retrospective Studies, Hypertrophy
- Abstract
This systematic review was conducted to determine factors that are associated with the degree of hypertrophy of the future liver remnant following portal vein embolization. An extensive search on September 15, 2020, and subsequent literature screening resulted in the inclusion of forty-eight articles with 3368 patients in qualitative analysis, of which 18 studies were included in quantitative synthesis. Meta-analyses based on a limited number of studies showed an increase in hypertrophy response when additional embolization of segment 4 was performed (pooled difference of medians = - 3.47, 95% CI - 5.51 to - 1.43) and the use of N-butyl cyanoacrylate for portal vein embolization induced more hypertrophy than polyvinyl alcohol (pooled standardized mean difference (SMD) = 0.60, 95% CI 0.30 to 0.91). There was no indication of a difference in degree of hypertrophy between patients who received neo-adjuvant chemotherapy and those who did not receive pre-procedural systemic therapy(pooled SMD = - 0.37, 95% CI - 1.35 to 0.61), or between male and female patients (pooled SMD = 0.19, 95% CI - 0.12 to 0.50).The study was registered in the International Prospective Register of Systematic Reviews on April 28, 2020 (CRD42020175708)., (© 2021. The Author(s).)
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- 2021
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46. Hospital variation in combined liver resection and thermal ablation for colorectal liver metastases and impact on short-term postoperative outcomes: a nationwide population-based study.
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Elfrink AKE, Nieuwenhuizen S, van den Tol MP, Burgmans MC, Prevoo W, Coolsen MME, van den Boezem PB, van Delden OM, Hagendoorn J, Patijn GA, Leclercq WKG, Liem MSL, Rijken AM, Verhoef C, Kuhlmann KFD, Ruiter SJS, Grünhagen DJ, Klaase JM, Kok NFM, Meijerink MR, and Swijnenburg RJ
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- Hepatectomy adverse effects, Hospitals, Humans, Retrospective Studies, Treatment Outcome, Colorectal Neoplasms surgery, Liver Neoplasms surgery
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Background: Combining resection and thermal ablation can improve short-term postoperative outcomes in patients with colorectal liver metastases (CRLM). This study assessed nationwide hospital variation and short-term postoperative outcomes after combined resection and ablation., Methods: In this population-based study, all CRLM patients who underwent resection in the Netherlands between 2014 and 2018 were included. After propensity score matching for age, ASA-score, Charlson-score, diameter of largest CRLM, number of CRLM and earlier resection, postoperative outcomes were compared. Postoperative complicated course (PCC) was defined as discharge after 14 days or a major complication or death within 30 days of surgery., Results: Of 4639 included patients, 3697 (80%) underwent resection and 942 (20%) resection and ablation. Unadjusted percentage of patients who underwent resection and ablation per hospital ranged between 4 and 44%. Hospital variation persisted after case-mix correction. After matching, 734 patients remained in each group. Hospital stay (median 6 vs. 7 days, p = 0.011), PCC (11% vs. 14.7%, p = 0.043) and 30-day mortality (0.7% vs. 2.3%, p = 0.018) were lower in the resection and ablation group. Differences faded in multivariable logistic regression due to inclusion of major hepatectomy., Conclusion: Significant hospital variation was observed in the Netherlands. Short-term postoperative outcomes were better after combined resection and ablation, attributed to avoiding complications associated with major hepatectomy., (Copyright © 2020 University Medical Center Groningen. Published by Elsevier Ltd.. All rights reserved.)
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- 2021
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47. Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial.
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Walma MS, Rombouts SJ, Brada LJH, Borel Rinkes IH, Bosscha K, Bruijnen RC, Busch OR, Creemers GJ, Daams F, van Dam RM, van Delden OM, Festen S, Ghorbani P, de Groot DJ, de Groot JWB, Haj Mohammad N, van Hillegersberg R, de Hingh IH, D'Hondt M, Kerver ED, van Leeuwen MS, Liem MS, van Lienden KP, Los M, de Meijer VE, Meijerink MR, Mekenkamp LJ, Nio CY, Oulad Abdennabi I, Pando E, Patijn GA, Polée MB, Pruijt JF, Roeyen G, Ropela JA, Stommel MWJ, de Vos-Geelen J, de Vries JJ, van der Waal EM, Wessels FJ, Wilmink JW, van Santvoort HC, Besselink MG, and Molenaar IQ
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- Antineoplastic Combined Chemotherapy Protocols adverse effects, Humans, Multicenter Studies as Topic, Netherlands, Progression-Free Survival, Randomized Controlled Trials as Topic, Pancreatic Neoplasms drug therapy, Pancreatic Neoplasms surgery, Radiofrequency Ablation adverse effects
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Background: Approximately 80% of patients with locally advanced pancreatic cancer (LAPC) are treated with chemotherapy, of whom approximately 10% undergo a resection. Cohort studies investigating local tumor ablation with radiofrequency ablation (RFA) have reported a promising overall survival of 26-34 months when given in a multimodal setting. However, randomized controlled trials (RCTs) investigating the effect of RFA in combination with chemotherapy in patients with LAPC are lacking., Methods: The "Pancreatic Locally Advanced Unresectable Cancer Ablation" (PELICAN) trial is an international multicenter superiority RCT, initiated by the Dutch Pancreatic Cancer Group (DPCG). All patients with LAPC according to DPCG criteria, who start with FOLFIRINOX or (nab-paclitaxel/)gemcitabine, are screened for eligibility. Restaging is performed after completion of four cycles of FOLFIRINOX or two cycles of (nab-paclitaxel/)gemcitabine (i.e., 2 months of treatment), and the results are assessed within a nationwide online expert panel. Eligible patients with RECIST stable disease or objective response, in whom resection is not feasible, are randomized to RFA followed by chemotherapy or chemotherapy alone. In total, 228 patients will be included in 16 centers in The Netherlands and four other European centers. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, RECIST response, CA 19.9 and CEA response, toxicity, quality of life, pain, costs, and immunomodulatory effects of RFA., Discussion: The PELICAN RCT aims to assess whether the combination of chemotherapy and RFA improves the overall survival when compared to chemotherapy alone, in patients with LAPC with no progression of disease following 2 months of systemic treatment., Trial Registration: Dutch Trial Registry NL4997 . Registered on December 29, 2015. ClinicalTrials.gov NCT03690323 . Retrospectively registered on October 1, 2018.
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- 2021
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48. Short- and long-term outcomes after hemihepatectomy for perihilar cholangiocarcinoma: does left or right side matter?
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Franken LC, Olthof PB, Erdmann JI, van Delden OM, Verheij J, Besselink MG, Busch OR, and van Gulik TM
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Background: The only potentially curative option for patients with perihilar cholangiocarcinoma (PHC) is resection, typically an extrahepatic bile duct resection in combination with (extended) liver resection. Complications such as bile leakage and liver failure have been suggested to be more common after right-sided resections compared to left-sided resections, whilst superior oncological outcomes have been reported after right-sided resections. However, data on outcomes after right-sided or left-sided liver resections in PHC are scarce. Therefore, we aimed to investigate short- and long-term outcomes after left and right hemihepatectomy in patients with PHC., Methods: In this retrospective study, patients undergoing major liver resection for suspected PHC in a tertiary center between 2000-2018 were included. Patients who had undergone left-sided resections were compared to patients with right-sided resections in terms of complications (90-day mortality, overall and severe morbidity and specific complications). For long-term outcomes, only patients with pathologically proven PHC were included in the survival analysis., Results: A total of 178 patients undergoing hemihepatectomy for suspected PHC were analysed, including 76 left-sided and 102 right-sided resections. Overall 90-day mortality was 14% (24 out of 178), with no significant difference after left-sided resection (11%; 8 out of 76) versus right-sided resection (16%; 16 out of 102) (P=0.319). Severe morbidity (Clavein Dindo ≥3) was also comparable in both groups: 54% versus 61% (P=0.361). No differences in specific complications including bile leakage were observed, although liver failure appeared to occur more frequently after right hemihepatectomy (22% versus 11%, P=0.052). Five-year overall survival for pathologically proven PHC, excluding in-hospital mortality, did not differ; 43.7% after left-sided resection vs . and 38.2% after right-sided resection (P=0.553)., Conclusions: Both short- and long-term outcomes between patients undergoing left and right hemihepatectomy for PHC were comparable. Post-hepatectomy liver failure was more common after right-sided resection., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/hbsn-19-948). TMvG serves as an unpaid editorial board member of Hepatobiliary Surgery and Nutrition. The other authors have no conflicts of interest to declare., (2021 Hepatobiliary Surgery and Nutrition. All rights reserved.)
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- 2021
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49. Renal biopsies performed before versus during ablation of T1 renal tumors: implications for prevention of overtreatment and follow-up.
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Widdershoven CV, Aarts BM, Zondervan PJ, Henderickx MMEL, Klompenhouwer EG, van Delden OM, Prevoo W, Montauban van Swijndregt AD, van Moorselaar RJA, Bex A, and Lagerveld BW
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- Biopsy, Follow-Up Studies, Humans, Medical Overuse prevention & control, Retrospective Studies, Carcinoma, Renal Cell, Kidney Neoplasms diagnostic imaging, Kidney Neoplasms surgery
- Abstract
Purpose: To assess the difference between renal mass biopsy (RMB) performed either before or during the ablation procedure., Methods: A retrospective multicenter study was performed in patients with a cT1 renal mass treated with ablation between January 2007 and July 2019, including a search in the national pathology database for patients with a RMB planned for ablation. Patient and tumor characteristics and information on malignant, benign, and non-diagnostic biopsy results were collected to establish rates of overtreatment and number of ablations avoided in case of benign or non-diagnostic histology., Results: RMB was performed in 714 patients, of which 231 patients received biopsy before planned ablation, and 483 patients at the time of ablation. Pathology results before ablation were malignant in 63% (145/231), benign in 20% (46/231) and non-diagnostic in 17% (40/231). Pathology results at the time of ablation were malignant in 67.5% (326/483), benign in 16.8% (81/483) and non-diagnostic in 15.7% (76/483), leading to a total of 32.5% of ablation of benign or non-diagnostic lesions. Of the patients with a benign biopsy obtained before ablation, 80.4% (37/46) chose not to undergo ablation. Patients with inconclusive biopsy before planned ablation chose an informed individualized approach including ablation, repeated biopsy, or no intervention in 56%, 34% and 10%., Conclusion: This study emphasizes the importance of obtaining a biopsy prior to the ablation procedure in a separate session to lower the rate of potentially unnecessary ablations.
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- 2021
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50. Trans-Arterial Embolization for Liver Hemangiomas: It's a New Dawn; It's a New Day; It's a New Life?
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Bilhim T, Golzarian J, and van Delden OM
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- 2021
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