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1. Optimised treatment of patients with enlarged lateral lymph nodes in rectal cancer: protocol of an international, multicentre, prospective registration study after extensive multidisciplinary training (LaNoReC)

Author

Susan Van Dieren, Joost Nederend, Pieter J Tanis, Roel Hompes, Klaas Havenga, Melissa W Taggart, Robert Riedl, Michail Doukas, Evert-Jan G. Boerma, Marinke Westerterp, Corrie A M Marijnen, Jaap Stoker, Andrew Ruszkiewicz, Tsuyoshi Konishi, Jarno Melenhorst, Karin Muller, Krista Gerbrands, Michael Croft, Michael Wilks, Johanne G. Bloemen, Peter A. Neijenhuis, Koen C.M.J. Peeters, Miranda Kusters, Martijn Intven, Jan Peringa, Maria Verseveld, Eline G M van Geffen, Tania C Sluckin, Sanne-Marije J A Hazen, Karin Horsthuis, Geerard Beets, Marilyne M Lange, Regina G H Beets-Tan, Marc R. W. Engelbrecht, Elisabeth D. Geijsen, Philip Meijnen, Jurriaan B. Tuynman, Ingrid M. Bruijnzeel, Bas Lamme, Femke M. Alberts, Rogier M. P. H. Crolla, Joanne Verdult, Johan H. Wijsman, Charlotte S. van Kessel, Erik Jan Mulder, Jan Binne Hulshoff, Ivan M. Cherepanin, Hans F. J. Fabry, G. Y. Mireille, Frank J. M. Kemper, Fatih Polat, Jacobus W. A. Burger, Jeltsje S. Cnossen, Shira H. de Bie, Robbert J. I. Bosker, Aaldert K. Talsma, Leonora S. F. Boogerd, Marc J. P. M. Govaert, Merel M. Scheurkogel, Imogeen E. Antonisse, Joost Rothbarth, Marianne de Vries, Marcel A. H. Ribbert, Anthony W. H. van de Ven, Susan ter Borg, Jennifer W. Bradshaw, Heleen M. Ceha, Fleur I. de Korte, Andreas W. K. S. Marinelli, Tjeerd S. Aukema, Liselotte W. van Bockel, Aukje A. J. M. van Tilborg, Tom Rozema, Amarins Brandsma, Stefan Hoogendoorn, Saskia R. Offerman, Hanneke Vos, Henderik L. van Westreenen, Jeroen W. A. Leijtens, Fabian A. Holman, Laura A. Velema, L Els, van Persijn van Meerten, Frans C. H. Bakers, Iryna Samarska, Nina Šefčovičová, Maaike Berbée, Bastiaan B. Pultrum, Dennis B. Rouw, Matthew Albert, L. René Arensman, Hanneke Basart, Esther C. J. Consten, Bart C.T. van de Laar, Inne Somers, Paul M. Verheijen, Thomas A. Fassaert, Christiaan Hoff, Eino B. van Duyn, Ellen M. Hendriksen, Hugo A.J. Gielkens, Arend G. J. Aalbers, Brechtje A. Grotenhuis, Michalda S. Dunker, Anne M. van Geel, Christof Meischl, W. Hermien Schreurs, Patty H. Spruit, Michael F. Gerhards, Thomas M. Karsten, Eveline J.T. Krul, Sebastiaan van Koeverden, Andre J. A. Bremers, Heidi Rütten, Johannes H. W. de Wilt, Mariska den Hartogh, Vera Oppedijk, Jan Willem T. Dekker, Debora Eschbach-Zandbergen, Daphne Roos, Arjan van Tilburg, Ernst Jan, Spillenaar Bilgen, Nikki Knijn, Marnix A. J. de Roos, Ilse van Dop, Tracy Fitzsimmons, Hidde M. Kroon, Michael Penniment, Mitchell Raeside, Tarik Sammour, Steven J. Oosterling, Jeroen A. W. Tielbeek, Ronald J. C. L. M. Vuylsteke, Erik J. R. J. van der Hoeven, Anke B. Smits, Anniek H. Boer, Edgar J. B. Furnée, Robbert J. de Haas, Manon N. G. J. A. Braat, Wilhelmina M. U. van Grevenstein, Milan C. Richir, Patricia J. A. M. Brouwers, Tilly Leseman, Eric H. J. Belgers, Jasenko Krdzalic, and Roy F. A. Vliegen

Subjects
Medicine
Abstract

Introduction Inadequate treatment of enlarged lateral lymph nodes (LLNs) in rectal cancer patients is associated with an increased lateral local recurrence (LLR) risk, despite neoadjuvant treatment and total mesorectal excision (TME) surgery. There is a promising role for LLN dissection (LLND) to lower this risk, but this challenging procedure requires appropriate training. This study protocol describes a prospective evaluation of oncological outcomes after standardised treatment based on multidisciplinary training, thereby aiming for a 50% reduction in LLR rate.Methods and analysis A prospective registration study will be opened in hospitals in which the involved multidisciplinary team members (radiologists, radiation oncologists, surgeons and pathologists) have received dedicated training to enhance knowledge and awareness of LLNs and in which standardised treatment including LLND has been implemented. Patients with rectal cancer and at least one enlarged LLN (short-axis ≥7.0 mm), or intermediate LLN (short-axis 5.0–6.9 mm) with at least one malignant feature on primary MRI, evaluated by a trained radiologist, are eligible. Patients will undergo neoadjuvant treatment by trained radiation oncologists, followed by TME surgery in combination with a minimally invasive, nerve-sparing LLND performed by trained surgeons. LLND specimens are evaluated by trained pathologists or grossing assistants. The primary outcome is LLR rate 3 years postoperatively. Secondary outcomes are morbidity, disease-free survival, overall survival and quality of life. To demonstrate a significant reduction in LLR rate from 13% (based on historical control data) to 6% after optimised treatment, 200 patients with enlarged LLNs are required.Ethics and dissemination The medical ethics board of the Vrije Universiteit Medical Centre (VUMC), the Netherlands, approved the study on 23 November 2022 (reference: 2021.0524). Participating centres must obtain local approval and participants are required to provide written informed consent. Results obtained from this study will be communicated via peer-reviewed medical journals and presentations at conferences.Trail registration number NCT04486131, 24 July 2020, https://clinicaltrials.gov/ct2/show/NCT04486131.

Published
2024
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2. Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6)

Author

Koen P. Rovers, Checca Bakkers, Geert A. A. M. Simkens, Jacobus W. A. Burger, Simon W. Nienhuijs, Geert-Jan M. Creemers, Anna M. J. Thijs, Alexandra R. M. Brandt-Kerkhof, Eva V. E. Madsen, Ninos Ayez, Nadine L. de Boer, Esther van Meerten, Jurriaan B. Tuynman, Miranda Kusters, Nina R. Sluiter, Henk M. W. Verheul, Hans J. van der Vliet, Marinus J. Wiezer, Djamila Boerma, Emma C. E. Wassenaar, Maartje Los, Cornelis B. Hunting, Arend G. J. Aalbers, Niels F. M. Kok, Koert F. D. Kuhlmann, Henk Boot, Myriam Chalabi, Schelto Kruijff, Lukas B. Been, Robert J. van Ginkel, Derk Jan A. de Groot, Rudolf S. N. Fehrmann, Johannes H. W. de Wilt, Andreas J. A. Bremers, Philip R. de Reuver, Sandra A. Radema, Karin H. Herbschleb, Wilhelmina M. U. van Grevenstein, Arjen J. Witkamp, Miriam Koopman, Nadia Haj Mohammad, Eino B. van Duyn, Walter J. B. Mastboom, Leonie J. M. Mekenkamp, Joost Nederend, Max J. Lahaye, Petur Snaebjornsson, Cornelis Verhoef, Hanneke W. M. van Laarhoven, Aeilko H. Zwinderman, Jeanette M. Bouma, Onno Kranenburg, Iris van ‘t Erve, Remond J. A. Fijneman, Marcel G. W. Dijkgraaf, Patrick H. J. Hemmer, Cornelis J. A. Punt, Pieter J. Tanis, Ignace H. J. T. de Hingh, Dutch Peritoneal Oncology Group (DPOG), and Dutch Colorectal Cancer Group (DCCG)

Subjects
Colorectal neoplasms, Peritoneal neoplasms, Cytoreduction surgical procedures, Hyperthermia, induced, Neoadjuvant therapy, Adjuvant chemotherapy, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Upfront cytoreductive surgery with HIPEC (CRS-HIPEC) is the standard treatment for isolated resectable colorectal peritoneal metastases (PM) in the Netherlands. This study investigates whether addition of perioperative systemic therapy to CRS-HIPEC improves oncological outcomes. Methods This open-label, parallel-group, phase II-III, randomised, superiority study is performed in nine Dutch tertiary referral centres. Eligible patients are adults who have a good performance status, histologically or cytologically proven resectable PM of a colorectal adenocarcinoma, no systemic colorectal metastases, no systemic therapy for colorectal cancer within six months prior to enrolment, and no previous CRS-HIPEC. Eligible patients are randomised (1:1) to perioperative systemic therapy and CRS-HIPEC (experimental arm) or upfront CRS-HIPEC alone (control arm) by using central randomisation software with minimisation stratified by a peritoneal cancer index of 0–10 or 11–20, metachronous or synchronous PM, previous systemic therapy for colorectal cancer, and HIPEC with oxaliplatin or mitomycin C. At the treating physician’s discretion, perioperative systemic therapy consists of either four 3-weekly neoadjuvant and adjuvant cycles of capecitabine with oxaliplatin (CAPOX), six 2-weekly neoadjuvant and adjuvant cycles of 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX), or six 2-weekly neoadjuvant cycles of 5-fluorouracil/leucovorin with irinotecan (FOLFIRI) followed by four 3-weekly (capecitabine) or six 2-weekly (5-fluorouracil/leucovorin) adjuvant cycles of fluoropyrimidine monotherapy. Bevacizumab is added to the first three (CAPOX) or four (FOLFOX/FOLFIRI) neoadjuvant cycles. The first 80 patients are enrolled in a phase II study to explore the feasibility of accrual and the feasibility, safety, and tolerance of perioperative systemic therapy. If predefined criteria of feasibility and safety are met, the study continues as a phase III study with 3-year overall survival as primary endpoint. A total of 358 patients is needed to detect the hypothesised 15% increase in 3-year overall survival (control arm 50%; experimental arm 65%). Secondary endpoints are surgical characteristics, major postoperative morbidity, progression-free survival, disease-free survival, health-related quality of life, costs, major systemic therapy related toxicity, and objective radiological and histopathological response rates. Discussion This is the first randomised study that prospectively compares oncological outcomes of perioperative systemic therapy and CRS-HIPEC with upfront CRS-HIPEC alone for isolated resectable colorectal PM. Trial registration Clinicaltrials.gov/NCT02758951, NTR/NTR6301, ISRCTN/ISRCTN15977568, EudraCT/2016–001865-99.

Published
2019
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3. Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial

Author

Vivian P. Bastiaenen, Charlotte E. L. Klaver, Niels F. M. Kok, Johannes H. W. de Wilt, Ignace H. J. T. de Hingh, Arend G. J. Aalbers, Djamila Boerma, Andre J. A. Bremers, Jacobus W. A. Burger, Eino B. van Duyn, Pauline Evers, Wilhelmina M. U. van Grevenstein, Patrick H. J. Hemmer, Eva V. E. Madsen, Petur Snaebjornsson, Jurriaan B. Tuynman, Marinus J. Wiezer, Marcel G. W. Dijkgraaf, Jarmila D. W. van der Bilt, and Pieter J. Tanis

Subjects
T4 colon cancer, Peritoneal metastases, Early detection, Diagnostic laparoscopy, Second/third look surgery, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Approximately 20–30% of patients with pT4 colon cancer develop metachronous peritoneal metastases (PM). Due to restricted accuracy of imaging modalities and absence of early symptoms, PM are often detected at a stage in which only a quarter of patients are eligible for curative intent treatment. Preliminary findings of the COLOPEC trial (NCT02231086) revealed that PM were already detected during surgical re-exploration within two months after primary resection in 9% of patients with pT4 colon cancer. Therefore, second look diagnostic laparoscopy (DLS) to detect PM at a subclinical stage may be considered an essential component of early follow-up in these patients, although this needs confirmation in a larger patient cohort. Furthermore, a third look DLS after a negative second look DLS might be beneficial for detection of PM occurring at a later stage. Methods The aim of this study is to determine the yield of second look DLS and added value of third look DLS after negative second look DLS in detecting occult PM in pT4N0-2 M0 colon cancer patients after completion of primary treatment. Patients will undergo an abdominal CT at 6 months postoperative, followed by a second look DLS within 1 month if no PM or other metastases not amenable for local treatment are detected. Patients without PM will subsequently be randomized between routine follow-up including 18 months abdominal CT, or an experimental arm with a third look DLS provided that PM or incurable metastases are absent at the 18 months abdominal CT. Primary endpoint is the proportion of PM detected after a negative second look DLS and will be determined at 20 months postoperative. Discussion Second look DLS is supposed to result in 10% occult PM, and third look DLS after negative second look DLS is expected to detect an additional 10% of PM compared to routine follow-up alone in patients with pT4 colon cancer. Detection of PM at an early stage will likely increase the proportion of patients eligible for curative intent treatment and subsequently improve survival, given the uniformly reported direct association between the extent of peritoneal disease and survival. Trial registration ClinicalTrials.gov: NCT03413254, January 2018.

Published
2019
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4. Endosonography With or Without Confirmatory Mediastinoscopy for Resectable Lung Cancer: A Randomized Clinical Trial

Author

Jelle E. Bousema, Marcel G.W. Dijkgraaf, Erik H.F.M. van der Heijden, Ad F.T.M. Verhagen, Jouke T. Annema, Frank J.C. van den Broek, Nicole E. Papen-Botterhuis, Maggy Youssef-El Soud, Wim J. van Boven, Johannes M.A. Daniels, David J. Heineman, Harmen R. Zandbergen, Pepijn Brocken, Thirza Horn, Willem H. Steup, Jerry Braun, Rajen S.R.S. Ramai, Naomi Beck, Fieke Hoeijmakers, Nicole P. Barlo, Martijn van Dorp, W. Hermien Schreurs, Anne-Marie C. Dingemans, Roy T.M. Sprooten, Jos G. Maessen, Niels J.M. Claessens, Jan-Willem H.P. Lardenoije, Birgitta I. Hiddinga, Caroline Van De Wauwer, Anthonie J. van der Wekken, Wessel E. Hanselaar, Robert ThJ Kortekaas, Martin P. Bard, Herman Rijna, Gerben P. Bootsma, Yvonne L.J. Vissers, Eelco J. Veen, Cor H. van der Leest, Emanuel Citgez, Eino B. van Duyn, Geertruid M.H. Marres, Eric R. van Thiel, Paul E. van Schil, Jan P. van Meerbeeck, Reinier Wener, Niels Smakman, Femke van der Meer, Mohammed D. Saboerali, Anne Marie Bosch, Wouter K. de Jong, Charles C. van Rossem, W. Johan Lie, Ewout A. Kouwenhoven, A. Jeske Staal-van den Brekel, Nike M. Hanneman, Roxane Heller-Baan, and Valentin J.J.M. Noyez

Subjects
Cancer Research, Oncology
Abstract

PURPOSE Resectable non–small-cell lung cancer (NSCLC) with a high probability of mediastinal nodal involvement requires mediastinal staging by endosonography and, in the absence of nodal metastases, confirmatory mediastinoscopy according to current guidelines. However, randomized data regarding immediate lung tumor resection after systematic endosonography versus additional confirmatory mediastinoscopy before resection are lacking. METHODS Patients with (suspected) resectable NSCLC and an indication for mediastinal staging after negative systematic endosonography were randomly assigned to immediate lung tumor resection or confirmatory mediastinoscopy followed by tumor resection. The primary outcome in this noninferiority trial (noninferiority margin of 8% that previously showed to not compromise survival, Pnoninferior < .0250) was the presence of unforeseen N2 disease after tumor resection with lymph node dissection. Secondary outcomes were 30-day major morbidity and mortality. RESULTS Between July 17, 2017, and October 5, 2020, 360 patients were randomly assigned, 178 to immediate lung tumor resection (seven dropouts) and 182 to confirmatory mediastinoscopy first (seven dropouts before and six after mediastinoscopy). Mediastinoscopy detected metastases in 8.0% (14/175; 95% CI, 4.8 to 13.0) of patients. Unforeseen N2 rate after immediate resection (8.8%) was noninferior compared with mediastinoscopy first (7.7%) in both intention-to-treat (Δ, 1.03%; UL 95% CIΔ, 7.2%; Pnoninferior = .0144) and per-protocol analyses (Δ, 0.83%; UL 95% CIΔ, 7.3%; Pnoninferior = .0157). Major morbidity and 30-day mortality was 12.9% after immediate resection versus 15.4% after mediastinoscopy first ( P = .4940). CONCLUSION On the basis of our chosen noninferiority margin in the rate of unforeseen N2, confirmatory mediastinoscopy after negative systematic endosonography can be omitted in patients with resectable NSCLC and an indication for mediastinal staging.

Published
2023

5. Adjuvant hyperthermic intraperitoneal chemotherapy in patients with locally advanced colon cancer (COLOPEC): a multicentre, open-label, randomised trial

Author

Ignace H. J. T. de Hingh, Erwin van der Harst, Victor J. Verwaal, Edwin S. van der Zaag, Karlijn van Woensdregt, R.T.J. Kortekaas, Bas Inberg, Sebastiaan Festen, Petur Snaebjornsson, Karin K. van Diepen, Anna A. W. van Geloven, Alexandra Brandt, Roderick F. Schmitz, Pieter J. Tanis, Koen C.M.J. Peeters, Cornelis J. A. Punt, Eva V. E. Madsen, Sanne C. Veltkamp, Charlotte E. L. Klaver, Johanne Bloemen, P.A. Neijenhuis, Eino B. van Duyn, Thomas J.M. Kootstra, Henderik L van Westreenen, Johannes H. W. de Wilt, T.C. van Sprundel, Emma C. E. Wassenaar, M. Westerterp, Philip R. de Reuver, Jennifer Demelinne, Dirkje W. Sommeijer, Loes van den Nieuwenhof, Marinus J. Wiezer, H.C.J. van der Mijle, Pauline Evers, Rogier M P H Crolla, Annette A van Zweeden, Joost T. Heikens, Daniel A. Hess, Marcel G. W. Dijkgraaf, Jan Jansen, D. J. A. Sonneveld, Anthony W. H. van de Ven, Frank W.H. Kloppenberg, Mandy Zournas, Patrick H. J. Hemmer, Koen P. Rovers, J. W. T. Dekker, Daniel D Wisselink, Jacobus W. A. Burger, Huib A. Cense, Esther D. van den Ende, David D. E. Zimmerman, Wilhelmina M U van Grevenstein, Frank C. den Boer, Jarmila D. W. van der Bilt, Sandra A Radema, Vivian P. Bastiaenen, Djamila Boerma, Johannes Crezee, Maarten Vermaas, Hans F. J. Fabry, Maartje Los, Floris Ferenschild, Lotte Schoonderwoerd, Walter J.A. Brokelman, Jeroen Heemskerk, Pieter Poortman, Jurriaan B. Tuynman, Johannes A. Wegdam, Marc J. van Det, Linda Mol, Bert van Ramshorst, Arend G. J. Aalbers, Marjolein Diepeveen, Gijsbert D. Musters, Arjen J. Witkamp, Daan ten Bokkel Huinink, Niels F. M. Kok, Simon W. Nienhuijs, Willem A. Bemelman, Geert-Jan Creemers, Jolien Pon, Caroline S. Andeweg, Sebastiaan W. Polle, Esther C. J. Consten, Nina R. Sluiter, Fennie Wit, A.J.A. Bremers, Surgery, AGEM - Re-generation and cancer of the digestive system, CCA - Cancer Treatment and quality of life, ​Robotics and image-guided minimally-invasive surgery (ROBOTICS), Graduate School, AGEM - Digestive immunity, CCA - Cancer Treatment and Quality of Life, Oncology, Radiotherapy, Epidemiology and Data Science, and APH - Methodology

Subjects
Male, SURGERY, Colorectal cancer, Kaplan-Meier Estimate, COLORECTAL-CANCER, law.invention, Postoperative Complications, 0302 clinical medicine, Randomized controlled trial, law, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, Intraoperative Complications, Laparoscopy, Colectomy, Peritoneal Neoplasms, RISK, education.field_of_study, medicine.diagnostic_test, Gastroenterology, Middle Aged, PERITONEAL CARCINOMATOSIS, Oxaliplatin, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Colonic Neoplasms, Female, 030211 gastroenterology & hepatology, Hyperthermic intraperitoneal chemotherapy, medicine.drug, medicine.medical_specialty, Perforation (oil well), Population, Adenocarcinoma, 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, SDG 3 - Good Health and Well-being, Journal Article, medicine, Humans, education, Aged, Neoplasm Staging, Hepatology, business.industry, Hyperthermia, Induced, Length of Stay, medicine.disease, Surgery, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], METASTASES, SYSTEMIC CHEMOTHERAPY, business
Abstract

BACKGROUND: Nearly a quarter of patients with locally advanced (T4 stage) or perforated colon cancer are at risk of developing peritoneal metastases, often without curative treatment options. We aimed to determine the efficacy of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with locally advanced colon cancer.METHODS: This multicentre, open-label trial was done in nine hospitals that specialised in HIPEC in the Netherlands. Patients with clinical or pathological T4N0-2M0-stage tumours or perforated colon cancer were randomly assigned (1:1), with a web-based randomisation application, before resection of the primary tumour, to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy (experimental group) or to adjuvant systemic chemotherapy alone (control group). Patients were stratified by tumour characteristic (T4 or perforation), age (FINDINGS: Between April 1, 2015, and Feb 20, 2017, 204 patients were randomly assigned to treatment (102 in each group). In the HIPEC group, two patients withdrew consent after randomisation. In this group, 19 (19%) of 100 patients were diagnosed with peritoneal metastases: nine (47%) during surgical exploration preceding intentional adjuvant HIPEC, eight (42%) during routine follow-up, and two (11%) during diagnostic laparoscopy at 18-months. In the control group, 23 (23%) of 102 patients were diagnosed with peritoneal metastases, of whom seven (30%) were diagnosed by laparoscopy at 18-months and 16 during regular follow-up (therefore making them ineligible for diagnostic laparoscopy). In the intention-to-treat analysis (n=202), there was no difference in peritoneal-free survival at 18-months (80·9% [95% CI 73·3-88·5] for the experimental group vs 76·2% [68·0-84·4] for the control group, log-rank one-sided p=0·28). 12 (14%) of 87 patients who received adjuvant HIPEC developed postoperative complications and one (1%) encapsulating peritoneal sclerosis.INTERPRETATION: In patients with T4 or perforated colon cancer, treatment with adjuvant HIPEC with oxaliplatin did not improve peritoneal metastasis-free survival at 18 months. Routine use of adjuvant HIPEC is not advocated on the basis of this trial.FUNDING: Organization for Health Research and Development and the Dutch Cancer Society.

Published
2019

6. Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial

Author

Jarmila D. W. van der Bilt, Marcel G. W. Dijkgraaf, Patrick H. J. Hemmer, Petur Snaebjornsson, Jacobus W. A. Burger, Charlotte E. L. Klaver, Djamila Boerma, Niels F. M. Kok, Jurriaan B. Tuynman, Pauline Evers, Arend G. J. Aalbers, Ignace H. J. T. de Hingh, A.J.A. Bremers, Marinus J. Wiezer, Wilhelmina M U van Grevenstein, Pieter J. Tanis, Eva V. E. Madsen, Eino B. van Duyn, Vivian P. Bastiaenen, Johannes H. W. de Wilt, Surgery, CCA - Cancer Treatment and Quality of Life, AGEM - Digestive immunity, AGEM - Re-generation and cancer of the digestive system, CCA - Imaging and biomarkers, Epidemiology and Data Science, APH - Methodology, and CCA - Cancer Treatment and quality of life

Subjects
0301 basic medicine, Male, Cancer Research, Colorectal cancer, CARCINOMATOSIS, Aftercare, COLORECTAL-CANCER, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], Study Protocol, 0302 clinical medicine, Surgical oncology, Clinical endpoint, Prospective Studies, Stage (cooking), Laparoscopy, Early Detection of Cancer, Peritoneal Neoplasms, Subclinical infection, Randomized Controlled Trials as Topic, RISK, OUTCOMES, medicine.diagnostic_test, ORIGIN, Early detection, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, 3. Good health, Oncology, 030220 oncology & carcinogenesis, Colonic Neoplasms, Hyperthermic intraperitoneal chemotherapy, Female, Radiology, HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY, Peritoneum, Adult, medicine.medical_specialty, Diagnostic laparoscopy, lcsh:RC254-282, CHEMOPERFUSION, 03 medical and health sciences, Young Adult, All institutes and research themes of the Radboud University Medical Center, SDG 3 - Good Health and Well-being, Genetics, medicine, Humans, T4 colon cancer, Aged, business.industry, technology, industry, and agriculture, Second, medicine.disease, Second/third look surgery, Occult, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], 030104 developmental biology, Peritoneal metastases, Clinical Trials, Phase III as Topic, Second-Look Surgery, third look surgery, CYTOREDUCTIVE SURGERY, CURATIVE TREATMENT, SYSTEMIC CHEMOTHERAPY, business
Abstract

Background Approximately 20–30% of patients with pT4 colon cancer develop metachronous peritoneal metastases (PM). Due to restricted accuracy of imaging modalities and absence of early symptoms, PM are often detected at a stage in which only a quarter of patients are eligible for curative intent treatment. Preliminary findings of the COLOPEC trial (NCT02231086) revealed that PM were already detected during surgical re-exploration within two months after primary resection in 9% of patients with pT4 colon cancer. Therefore, second look diagnostic laparoscopy (DLS) to detect PM at a subclinical stage may be considered an essential component of early follow-up in these patients, although this needs confirmation in a larger patient cohort. Furthermore, a third look DLS after a negative second look DLS might be beneficial for detection of PM occurring at a later stage. Methods The aim of this study is to determine the yield of second look DLS and added value of third look DLS after negative second look DLS in detecting occult PM in pT4N0-2 M0 colon cancer patients after completion of primary treatment. Patients will undergo an abdominal CT at 6 months postoperative, followed by a second look DLS within 1 month if no PM or other metastases not amenable for local treatment are detected. Patients without PM will subsequently be randomized between routine follow-up including 18 months abdominal CT, or an experimental arm with a third look DLS provided that PM or incurable metastases are absent at the 18 months abdominal CT. Primary endpoint is the proportion of PM detected after a negative second look DLS and will be determined at 20 months postoperative. Discussion Second look DLS is supposed to result in 10% occult PM, and third look DLS after negative second look DLS is expected to detect an additional 10% of PM compared to routine follow-up alone in patients with pT4 colon cancer. Detection of PM at an early stage will likely increase the proportion of patients eligible for curative intent treatment and subsequently improve survival, given the uniformly reported direct association between the extent of peritoneal disease and survival. Trial registration ClinicalTrials.gov: NCT03413254, January 2018. Electronic supplementary material The online version of this article (10.1186/s12885-019-5408-8) contains supplementary material, which is available to authorized users.

Published
2019

7. Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD): A Multicenter Patient-blinded Randomized Controlled Trial

Author

Jony van Hilst, Misha D. P. Luyer, Sebastiaan Festen, Moh'd Abu Hilal, Ignace H. J. T. de Hingh, Joost M. Klaase, Mustafa Suker, Geert Kazemier, Olivier R. Busch, Freek Daams, Peter B. van den Boezem, Marcel G. W. Dijkgraaf, Hjalmar C. van Santvoort, Michael F. Gerhards, Marc G. Besselink, Eino B. van Duyn, Cees H. Dejong, Ruben H J de Kleine, Ronald M. van Dam, Cornelis J. H. M. van Laarhoven, Pascal Steenvoorde, Casper H.J. van Eijck, Djamila Boerma, Gijs A. Patijn, Thijs de Rooij, Bas Groot Koerkamp, RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Heelkunde (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Surgery, Erasmus MC other, Groningen Institute for Organ Transplantation (GIOT), Value, Affordability and Sustainability (VALUE), CCA - Cancer Treatment and quality of life, and AGEM - Re-generation and cancer of the digestive system

Subjects
medicine.medical_specialty, Percutaneous, LONG-TERM, SURGERY, BENIGN, robot-assisted, laparoscopic, law.invention, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, Interquartile range, Clinical endpoint, Medicine, distal pancreatectomy, pancreatic surgery, IDEAL FRAMEWORK, IDEAL, METAANALYSIS, PANCREAS, Intention-to-treat analysis, Gastric emptying, business.industry, Retrospective cohort study, Surgery, 030220 oncology & carcinogenesis, minimally invasive, 030211 gastroenterology & hepatology, business
Abstract

Objective: This trial followed a structured nationwide training program in minimally invasive distal pancreatectomy (MIDP), according to the IDEAL framework for surgical innovation, and aimed to compare time to functional recovery after minimally invasive and open distal pancreatectomy (ODP).Background: MIDP is increasingly used and may enhance postoperative recovery as compared with ODP, but randomized studies are lacking.Methods: A multicenter patient-blinded randomized controlled superiority trial was performed in 14 centers between April 2015 and March 2017. Adult patients with left-sided pancreatic tumors confined to the pancreas without vascular involvement were randomly assigned (1:1) to undergo MIDP or ODP. Patients were blinded for type of surgery using a large abdominal dressing. The primary endpoint was time to functional recovery. Analysis was by intention to treat. This trial was registered with the Netherlands Trial Register (NTR5689).Results: Time to functional recovery was 4 days [interquartile range (IQR) 3-6) in 51 patients after MIDP versus 6 days (IQR 5-8) in 57 patients after ODP (P = III complication rate was 25% versus 38% (P = 0.21). Delayed gastric emptying grade B/C was seen less often after MIDP (6% vs 20%; P = 0.04). Postoperative pancreatic fistulas grade B/C were seen in 39% after MIDP versus 23% after ODP (P = 0.07), without difference in percutaneous catheter drainage (22% vs 20%; P = 0.77). Quality of life (day 3-30) was better after MIDP as compared with ODP, and overall costs were non-significantly less after MIDP. No 90-day mortality was seen after MIDP versus 2% (n = 1) after ODP.Conclusions: In patients with left-sided pancreatic tumors confined to the pancreas, MIDP reduces time to functional recovery compared with ODP. Although the overall rate of complications was not reduced, MIDP was associated with less delayed gastric emptying and better quality of life without increasing costs.

Published
2019

8. An International Collaborative Standardizing a Comprehensive Patient-Centered Outcomes Measurement Set for Colorectal Cancer

Author

Josep M. Borràs, Melissa P. Upton, Ann M. Berger, Veena Shankaran, Skye Hung-Chun Cheng, Eino B. van Duyn, Cornelis J.H. van de Velde, Harvey J. Mamon, Annelotte C. M. van Bommel, Muhammad R. Abu Hassan, Samuel R.G. Finlayson, Pamela K. McAllister, Corinna Langelotz, Bruce D. Minsky, Mary K. Buss, Gilles Boland, A. C. Lynch, Eric Van Cutsem, Maartje Gisele Schouwenburg, Kim Ryan, Caleb Stowell, Donna Bauer, John Zalcberg, Robert R. Cima, John Lloyd, Joanne Ngeow, Rob A. E. M. Tollenaar, Jessica A. Zerillo, and Jacob Lippa

Subjects
Cancer Research, medicine.medical_specialty, Palliative care, Delphi Technique, International Cooperation, MEDLINE, law.invention, 03 medical and health sciences, 0302 clinical medicine, Quality of life (healthcare), Randomized controlled trial, law, Health care, medicine, Global health, Humans, 030212 general & internal medicine, Patient Reported Outcome Measures, Quality of Health Care, business.industry, Patient-centered outcomes, Focus Groups, Focus group, Oncology, 030220 oncology & carcinogenesis, Family medicine, Quality of Life, business, Colorectal Neoplasms
Abstract

Importance Global health systems are shifting toward value-based care in an effort to drive better outcomes in the setting of rising health care costs. This shift requires a common definition of value, starting with the outcomes that matter most to patients. Objective The International Consortium for Health Outcomes Measurement (ICHOM), a nonprofit initiative, was formed to define standard sets of outcomes by medical condition. In this article, we report the efforts of ICHOM’s working group in colorectal cancer. Evidence Review The working group was composed of multidisciplinary oncology specialists in medicine, surgery, radiation therapy, palliative care, nursing, and pathology, along with patient representatives. Through a modified Delphi process during 8 months (July 8, 2015 to February 29, 2016), ICHOM led the working group to a consensus on a final recommended standard set. The process was supported by a systematic PubMed literature review (1042 randomized clinical trials and guidelines from June 3, 2005, to June 3, 2015), a patient focus group (11 patients with early and metastatic colorectal cancer convened during a teleconference in August 2015), and a patient validation survey (among 276 patients with and survivors of colorectal cancer between October 15, 2015, and November 4, 2015). Findings After consolidating findings of the literature review and focus group meeting, a list of 40 outcomes was presented to the WG and underwent voting. The final recommendation includes outcomes in the following categories: survival and disease control, disutility of care, degree of health, and quality of death. Selected case-mix factors were recommended to be collected at baseline to facilitate comparison of results across treatments and health care professionals. Conclusions A standardized set of patient-centered outcome measures to inform value-based health care in colorectal cancer was developed. Pilot efforts are under way to measure the standard set among members of the working group.

Published
2017

9. Recurrences After Conventional Anterior and Laparoscopic Inguinal Hernia Repair: A Randomized Comparison

Author

M. S. L. Liem, Eino B. van Duyn, Theo J. M. V. van Vroonhoven, and Yolanda van der Graaf

Subjects
Adult, Male, medicine.medical_specialty, Randomization, Physical examination, Hernia, Inguinal, law.invention, Abdominal wall, Age Distribution, Randomized controlled trial, law, Recurrence, Risk Factors, medicine, Confidence Intervals, Odds Ratio, Humans, Hernia, Sex Distribution, Aged, Pain Measurement, Probability, Analysis of Variance, Laparotomy, Pain, Postoperative, medicine.diagnostic_test, business.industry, General surgery, Incidence, Odds ratio, Original Articles, Middle Aged, medicine.disease, Surgery, Clinical trial, Inguinal hernia, medicine.anatomical_structure, Treatment Outcome, Female, Laparoscopy, business, Follow-Up Studies
Abstract

To study the long-term recurrence rate and other complications after conventional and laparoscopic inguinal hernia repair.Reliable long-term follow-up of patients with inguinal hernias treated by laparoscopic repair techniques is lacking.The authors performed a randomized, multicenter trial in which 487 patients with inguinal hernia were treated by totally extraperitoneal laparoscopic repair and 507 patients were treated by conventional anterior hernia repair. Patients were followed and examined for recurrence and chronic inguinal pain 2, 3, and 5 years after surgery. Risk factors for recurrence and chronic inguinal pain were assessed.Patients who underwent conventional repair had a high risk for recurrence compared to patients who underwent laparoscopic repair. Risk factors for recurrence were operative time and type of conventional repair. Predictive independent risk factors for chronic inguinal pain were conventional repair (Bassini repairs and non-bassini repairs), inguinal pain before surgery, and perioperative lesion of the ilioinguinal nerve.Patients with inguinal hernia who undergo laparoscopic repair have fewer recurrences and less chronic inguinal pain than those who undergo conventional open repair. The Bassini repair produces unacceptably high recurrence rates.

Published
2003

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