16 results on '"Besselink, Marc Gh"'
Search Results
2. Minimally invasive intervention for infected necrosis in acute pancreatitis
- Author
-
Hollemans, Robbert A, van Brunschot, Sandra, Bakker, Olaf J, Bollen, Thomas L, Timmer, Robin, Besselink, Marc GH, and van Santvoort, Hjalmar C
- Published
- 2014
- Full Text
- View/download PDF
3. Opinions and use of neoadjuvant therapy for resectable, borderline resectable, and locally advanced pancreatic cancer: International survey and case-vignette study
- Author
-
Heinrich, Stefan, Besselink, Marc GH, Moehler, Markus, Van Laethem, Jean-Luc, Ducreux, Michel, Grimminger, Peter, Mittler, Jens, Lang, Hauke, Lutz, Manfred M.P., Lesurtel, Mickael, Heinrich, Stefan, Besselink, Marc GH, Moehler, Markus, Van Laethem, Jean-Luc, Ducreux, Michel, Grimminger, Peter, Mittler, Jens, Lang, Hauke, Lutz, Manfred M.P., and Lesurtel, Mickael
- Abstract
Background: Several new treatment options have become available for pancreatic ductal adenocarcinoma (PDAC), but the support for their use for resectable, borderline resectable and locally advanced PDAC is unclear. Methods: A survey was distributed to the members of the European-African Hepato-Pancreato Biliary Association (E-AHPBA) and the pancreas group of the European Organization for Research and Treatment of Cancer (EORTC) regarding 1) definitions of local resectability, 2) indications for neoadjuvant therapy and 3) case-vignettes regarding the resectability and treatment of PDAC. Results: In total, 114 participants from 37 countries were registered. About 35% of respondents, each, were of the opinion that borderline resectability is defined by any venous tumor contact and venous involvement < 180° or > 180°, respectively. The majority (75.4%) of participants believed that borderline resectable PDAC has a high risk for R1 resection and that neoadjuvant therapy might increase the R0-resection rate (79.8%) and improve oncological patient selection (84.2%). Chemotherapy was regarded useful to convert locally advanced to resectable PDAC by 55.7% of respondents. In the cases with resectable, borderline resectable, and locally advanced PDAC, 10 (8.8%), 78 (68.4%), 55 (48.2%) of participants would start with chemotherapy, respectively. Conclusions: Although definitions for borderline resectability differ among European surgeons, there seems to be a rather strong support for preoperative chemotherapy in PDAC aiming at minimizing R1 resections while increasing resection rates., SCOPUS: ar.j, info:eu-repo/semantics/published
- Published
- 2019
4. Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial)
- Author
-
van der Sluis Pieter C, Ruurda Jelle P, van der Horst Sylvia, Verhage Roy JJ, Besselink Marc GH, Prins Margriet JD, Haverkamp Leonie, Schippers Carlo, Rinkes Inne HM Borel, Joore Hans CA, ten Kate Fiebo JW, Koffijberg Hendrik, Kroese Christiaan C, van Leeuwen Maarten S, Lolkema Martijn PJK, Reerink Onne, Schipper Marguerite EI, Steenhagen Elles, Vleggaar Frank P, Voest Emile E, Siersema Peter D, and van Hillegersberg Richard
- Subjects
Medicine (General) ,R5-920 - Abstract
Abstract Background For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%). Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE) is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer. Methods/design This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥18 and ≤80 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 112) with resectable esophageal cancer are randomized in the outpatient department to either RATE (n = 56) or open three-stage transthoracic esophageal resection (n = 56). The primary outcome of this study is the percentage of overall complications (grade 2 and higher) as stated by the modified Clavien–Dindo classification of surgical complications. Discussion This is the first randomized controlled trial designed to compare RATE with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient. Trial registration Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790
- Published
- 2012
- Full Text
- View/download PDF
5. Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial
- Author
-
Kortram Kirsten, van Ramshorst Bert, Bollen Thomas L, Besselink Marc GH, Gouma Dirk J, Karsten Tom, Kruyt Philip M, Nieuwenhuijzen Grard AP, Kelder Johannes C, Tromp Ellen, and Boerma Djamila
- Subjects
Acute cholecystitis ,laparoscopic cholecystectomy ,percutaneous cholecystostomy ,percutaneous drainage ,Medicine (General) ,R5-920 - Abstract
Abstract Background Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. Methods/Design The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs. Discussion The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients. Trial Registration Netherlands Trial Register (NTR): NTR2666
- Published
- 2012
- Full Text
- View/download PDF
6. Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease
- Author
-
ter Veer, Emil, Van Cutsem, Eric, Deplanque, Gael, Friess, Helmut, Glimelius, Bengt, Goldstein, David, Herrmann, Richard, Labianca, Roberto, Van Laethem, Jean-Luc, Macarulla, Teresa, van der Meer, Jonathan J.H.M., van Rijssen, Lennart Bengt, Neoptolemos, John, Okusaka, Takuji, O'Reilly, Eileen Mary, Pelzer, Uwe, Philip, Philip Agop, van der Poel, Marcel M.J., Reni, Michele, Scheithauer, Werner, Siveke, Jens J.T., Verslype, Chris, Besselink, Marc GH, Busch, Olivier O.R., Wilmink, Johanna J.W., van Oijen, Martijn Gh M.G.H., van Laarhoven, Hanneke Wm H.W.M., Mali, Rosa R.M.A., Berlin, Jordan J.D., Boeck, Stefan, Bonnetain, Franck, Chau, Ian, Conroy, Thierry, ter Veer, Emil, Van Cutsem, Eric, Deplanque, Gael, Friess, Helmut, Glimelius, Bengt, Goldstein, David, Herrmann, Richard, Labianca, Roberto, Van Laethem, Jean-Luc, Macarulla, Teresa, van der Meer, Jonathan J.H.M., van Rijssen, Lennart Bengt, Neoptolemos, John, Okusaka, Takuji, O'Reilly, Eileen Mary, Pelzer, Uwe, Philip, Philip Agop, van der Poel, Marcel M.J., Reni, Michele, Scheithauer, Werner, Siveke, Jens J.T., Verslype, Chris, Besselink, Marc GH, Busch, Olivier O.R., Wilmink, Johanna J.W., van Oijen, Martijn Gh M.G.H., van Laarhoven, Hanneke Wm H.W.M., Mali, Rosa R.M.A., Berlin, Jordan J.D., Boeck, Stefan, Bonnetain, Franck, Chau, Ian, and Conroy, Thierry
- Abstract
Variations in the reporting of potentially confounding variables in studies investigating systemic treatments for unresectable pancreatic cancer pose challenges in drawing accurate comparisons between findings. In this Review, we establish the first international consensus on mandatory baseline and prognostic characteristics in future trials for the treatment of unresectable pancreatic cancer. We did a systematic literature search to find phase 3 trials investigating first-line systemic treatment for locally advanced or metastatic pancreatic cancer to identify baseline characteristics and prognostic variables. We created a structured overview showing the reporting frequencies of baseline characteristics and the prognostic relevance of identified variables. We used a modified Delphi panel of two rounds involving an international panel of 23 leading medical oncologists in the field of pancreatic cancer to develop a consensus on the various variables identified. In total, 39 randomised controlled trials that had data on 15 863 patients were included, of which 32 baseline characteristics and 26 prognostic characteristics were identified. After two consensus rounds, 23 baseline characteristics and 12 prognostic characteristics were designated as mandatory for future pancreatic cancer trials. The COnsensus statement on Mandatory Measurements in unresectable PAncreatic Cancer Trials (COMM-PACT) identifies a mandatory set of baseline and prognostic characteristics to allow adequate comparison of outcomes between pancreatic cancer studies., SCOPUS: re.j, info:eu-repo/semantics/published
- Published
- 2018
7. Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868]
- Author
-
Houdijk Lex PJ, Hesselink Eric J, van der Harst Erwin, Gouma Dirk J, Consten Esther CJ, Cuesta Miguel A, Schaapherder Alexander FM, van Ramshorst Bert, Ploeg Rutger J, van Leeuwen Maarten S, Lameris Johan S, Hofker Sijbrand S, van Goor Harry, van Eijck Casper HJ, Dejong Cornelis HC, Buskens Erik, Bollen Thomas L, Boermeester Marja A, Nieuwenhuijs Vincent B, van Santvoort Hjalmar C, Besselink Marc GH, Karsten Tom M, van Laarhoven Cees JHM, Pierie Jean-Pierre EN, Rosman Camiel, Bilgen Ernst, Timmer Robin, van der Tweel Ingeborg, de Wit Ralph J, Witteman Ben JM, and Gooszen Hein G
- Subjects
Surgery ,RD1-811 - Abstract
Abstract Background The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. Methods/design 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect) costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated. Discussion The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected) infected necrotizing pancreatitis.
- Published
- 2006
- Full Text
- View/download PDF
8. Probiotic prophylaxis in patients with predicted severe acute pancreatitis (PROPATRIA): design and rationale of a double-blind, placebo-controlled randomised multicenter trial [ISRCTN38327949]
- Author
-
Akkermans Louis MA, Nieuwenhuijs Vincent B, Buskens Erik, Timmerman Harro M, Besselink Marc GH, and Gooszen Hein G
- Subjects
Surgery ,RD1-811 - Abstract
Abstract Background Infectious complications are the major cause of death in acute pancreatitis. Small bowel bacterial overgrowth and subsequent bacterial translocation are held responsible for the vast majority of these infections. Goal of this study is to determine whether selected probiotics are capable of preventing infectious complications without the disadvantages of antibiotic prophylaxis; antibiotic resistance and fungal overgrowth. Methods/design PROPATRIA is a double-blind, placebo-controlled randomised multicenter trial in which 200 patients will be randomly allocated to a multispecies probiotic preparation (Ecologic 641) or placebo. The study is performed in all 8 Dutch University Hospitals and 7 non-University hospitals. The study-product is administered twice daily through a nasojejunal tube for 28 days or until discharge. Patients eligible for randomisation are adult patients with a first onset of predicted severe acute pancreatitis: Imrie criteria 3 or more, CRP 150 mg/L or more, APACHE II score 8 or more. Exclusion criteria are post-ERCP pancreatitis, malignancy, infection/sepsis caused by a second disease, intra-operative diagnosis of pancreatitis and use of probiotics during the study. Administration of the study product is started within 72 hours after onset of abdominal pain. The primary endpoint is the total number of infectious complications. Secondary endpoints are mortality, necrosectomy, antibiotic resistance, hospital stay and adverse events. To demonstrate that probiotic prophylaxis reduces the proportion of patients with infectious complications from 50% to 30%, with alpha 0,05 and power 80%, a total sample size of 200 patients was calculated. Conclusion The PROPATRIA study is aimed to show a reduction in infectious complications due to early enteral use of multispecies probiotics in severe acute pancreatitis.
- Published
- 2004
- Full Text
- View/download PDF
9. Outcomes after conservative, endoscopic, and surgical treatment of groove pancreatitis: A systematic review
- Author
-
Kager, Liesbeth L.M., Lekkerkerker, Selma S.J., Arvanitakis, Marianna, Delhaye, Myriam, Fockens, Paul, Boermeester, M.A., van Hooft, Jeanin E, Besselink, Marc GH, Kager, Liesbeth L.M., Lekkerkerker, Selma S.J., Arvanitakis, Marianna, Delhaye, Myriam, Fockens, Paul, Boermeester, M.A., van Hooft, Jeanin E, and Besselink, Marc GH
- Abstract
Background: Groove pancreatitis (GP) is a focal form of chronic pancreatitis affecting the paraduodenal groove area, for which consensus on diagnosis and management is lacking. Goals: We performed a systematic review of the literature to determine patient characteristics and imaging features of GP and to evaluate clinical outcomes after treatment. Results: Eight studies were included reporting on 335 GP patients with a median age of 47 years (range, 34 to 64 y), with 90% male, 87% smokers, and 87% alcohol consumption, and 47 months (range, 15 to 122 mo) of follow-up. Most patients presented with abdominal pain (91%) and/or weight loss (78%). Imaging frequently showed cystic lesions (91%) and duodenal stenosis (60%). Final treatment was conservative (eg, pain medication) in 29% of patients. Endoscopic treatment (eg, pseudocyst drainage) was applied in 19% of patients-34% of these patients were subsequently referred for surgery. Overall, 59% of patients were treated surgically (eg, pancreatoduodenectomy). Complete symptom relief was observed in 50% of patients who were treated conservatively, 57% who underwent endoscopic treatment, and 79% who underwent surgery. Conclusions: GP is associated with male gender, smoking, and alcohol consumption. The vast majority of patients presents with abdominal pain and with cystic lesions on imaging. Although surgical treatment seems to be the most effective, both conservative and endoscopic treatment are successful in about half of patients. A stepwise treatment algorithm starting with the least invasive treatment options seems advisable., SCOPUS: re.j, info:eu-repo/semantics/published
- Published
- 2017
10. Minimally invasive pancreatoduodenectomy
- Author
-
Kendrick, Michael L., primary, van Hilst, Jony, additional, Boggi, Ugo, additional, de Rooij, Thijs, additional, Walsh, R. Matthew, additional, Zeh, Herbert J., additional, Hughes, Steven J., additional, Nakamura, Yoshiharu, additional, Vollmer, Charles M., additional, Kooby, David A., additional, Asbun, Horacio J., additional, Barkun, Jeffrey, additional, Besselink, Marc GH., additional, Conlon, Kevin CP., additional, Han, Ho-Seong, additional, Hansen, Paul D., additional, Kendrick, Michael L., additional, Montagnini, Andre L., additional, Palanivelu, C., additional, Røsok, Bård I., additional, Shrikhande, Shailesh V., additional, Wakabayashi, Go, additional, and Zeh, Herbert, additional
- Published
- 2017
- Full Text
- View/download PDF
11. Suboptimal care for chronic pancreatitis patients revealed by moderate to low adherence to the United European Gastroenterology evidence-based guidelines (HaPanEU): A Netherlands nationwide analysis
- Author
-
Rijk, Florence EM, Kempeneers, Marinus A, Bruno, Marco J, Besselink, Marc GH, Goor, Harry, Boermeester, Marja A, Geenen, Erwin JM, Hooft, Jeanin E, Santvoort, Hjalmar C, and Verdonk, Robert C
- Abstract
The 2016, United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (HaPanEU) provided evidence-based recommendations for the management of chronic pancreatitis and allowed for the objective evaluation of the quality of care in several domains of disease management through assessment of guideline adherence. Therefore, the aim of this study is to evaluate the current level and the variety of care for chronic pancreatitis patients in the Netherlands using the HaPanEU guidelines as a reference standard. The majority of these patients were diagnosed before the publication of these guidelines. Therefore, in most patients, the results of the present study with respect to those recommendations regarding the diagnostic process of chronic pancreatitis represent guideline correspondence and not adherence. A subgroup of patients from the Dutch nationwide chronic pancreatitis registry (CARE) was included in a retrospective cross-sectional observational cohort study. A total of 39 recommendations concerning the non-invasive management of chronic pancreatitis were appointed as quality indicators (QIs). Per patient, the number of relevant QIs was determined and guideline adherence was assessed. Data were analyzed to identify factors associated with guideline adherence. Overall, 97 patients with chronic pancreatitis from 11 hospitals were included. Per patient, a mean number of 26 relevant QIs was applicable, with an average adherence rate of 53%. In 45% of the patients, guideline adherence was less than 50%. The majority of suboptimal managed QIs concerned the management of chronic pancreatitis complications. Guideline adherence was not associated with hospital type, sex, age or etiology of pancreatitis. In the Netherlands, adherence to the HaPanEU recommendations for the management of chronic pancreatitis is moderate to low for all non-invasive domains, which may indicate suboptimal care for these patients. Closer guideline adherence could improve the level of care and the clinical outcomes of these patients. A nationwide approach to increase awareness of the key guideline recommendations among clinicians and patients is needed.
- Published
- 2020
- Full Text
- View/download PDF
12. Suboptimal care for chronic pancreatitis patients revealed by moderate to low adherence to the United European Gastroenterology evidence-based guidelines (HaPanEU): A Netherlands nationwide analysis
- Author
-
de Rijk, Florence EM, Kempeneers, Marinus A, Bruno, Marco J, Besselink, Marc GH, van Goor, Harry, Boermeester, Marja A, van Geenen, Erwin JM, van Hooft, Jeanin E, van Santvoort, Hjalmar C, and Verdonk, Robert C
- Abstract
Background and objective The 2016, United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (HaPanEU) provided evidence-based recommendations for the management of chronic pancreatitis and allowed for the objective evaluation of the quality of care in several domains of disease management through assessment of guideline adherence. Therefore, the aim of this study is to evaluate the current level and the variety of care for chronic pancreatitis patients in the Netherlands using the HaPanEU guidelines as a reference standard. The majority of these patients were diagnosed before the publication of these guidelines. Therefore, in most patients, the results of the present study with respect to those recommendations regarding the diagnostic process of chronic pancreatitis represent guideline correspondence and not adherence.Methods A subgroup of patients from the Dutch nationwide chronic pancreatitis registry (CARE) was included in a retrospective cross-sectional observational cohort study. A total of 39 recommendations concerning the non-invasive management of chronic pancreatitis were appointed as quality indicators (QIs). Per patient, the number of relevant QIs was determined and guideline adherence was assessed. Data were analyzed to identify factors associated with guideline adherence.Results Overall, 97 patients with chronic pancreatitis from 11 hospitals were included. Per patient, a mean number of 26 relevant QIs was applicable, with an average adherence rate of 53%. In 45% of the patients, guideline adherence was less than 50%. The majority of suboptimal managed QIs concerned the management of chronic pancreatitis complications. Guideline adherence was not associated with hospital type, sex, age or etiology of pancreatitis.Conclusion In the Netherlands, adherence to the HaPanEU recommendations for the management of chronic pancreatitis is moderate to low for all non-invasive domains, which may indicate suboptimal care for these patients. Closer guideline adherence could improve the level of care and the clinical outcomes of these patients. A nationwide approach to increase awareness of the key guideline recommendations among clinicians and patients is needed.
- Published
- 2020
- Full Text
- View/download PDF
13. Comment to: Månsson C, Nilsson A, Karlson B-M. Severe complications with irreversible electroporation of the pancreas in the presence of a metallic stent: a warning of a procedure that never should be performed. Acta Radiologica Short Reports 2014;3(11):1–3.
- Author
-
Scheffer, Hester J, primary, Vogel, Jantien A, additional, van den Bos, Willemien, additional, Meijerink, Martijn R, additional, Besselink, Marc GH, additional, Verdaasdonk, Rudolf M, additional, Klaessens, John, additional, van der Geld, Cees WM, additional, and van Gemert, Martin JC, additional
- Published
- 2015
- Full Text
- View/download PDF
14. Preoperative endoscopic versus percutaneous transhepatic biliary drainage in potentially resectable perihilar cholangiocarcinoma (DRAINAGE trial): design and rationale of a randomized controlled trial
- Author
-
Wiggers, Jimme K, primary, Coelen, Robert JS, additional, Rauws, Erik AJ, additional, van Delden, Otto M, additional, van Eijck, Casper HJ, additional, de Jonge, Jeroen, additional, Porte, Robert J, additional, Buis, Carlijn I, additional, Dejong, Cornelis HC, additional, Molenaar, I Quintus, additional, Besselink, Marc GH, additional, Busch, Olivier RC, additional, Dijkgraaf, Marcel GW, additional, and van Gulik, Thomas M, additional
- Published
- 2015
- Full Text
- View/download PDF
15. Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN38327949]
- Author
-
Besselink, Marc GH, van Santvoort, Hjalmar C, Nieuwenhuijs, Vincent B, Boermeester, Marja A, Bollen, Thomas L, Buskens, Erik, Dejong, Cornelis HC, van Eijck, Casper HJ, van Goor, Harry, Hofker, Sijbrand S, Lameris, Johan S, van Leeuwen, Maarten S, Ploeg, Rutger J, van Ramshorst, Bert, Schaapherder, Alexander FM, Cuesta, Miguel A, Consten, Esther CJ, Gouma, Dirk J, van der Harst, Erwin, Hesselink, Eric J, Houdijk, Lex PJ, Karsten, Tom M, van Laarhoven, Cees JHM, Pierie, Jean-Pierre EN, Rosman, Camiel, Bilgen, Ernst Jan Spillenaar, Timmer, Robin, van der Tweel, Ingeborg, de Wit, Ralph J, Witteman, Ben JM, and Gooszen, Hein G
- Subjects
Postoperative Care ,Pathogenesis and modulation of inflammation [N4i 1] ,Study Protocol ,Laparotomy ,Pancreatitis, Acute Necrotizing ,Evaluation of complex medical interventions [NCEBP 2] ,Drainage ,Humans ,Video-Assisted Surgery ,Microbial pathogenesis and host defense [UMCN 4.1] ,Therapeutic Irrigation - Abstract
Contains fulltext : 49444.pdf ( ) (Open Access) BACKGROUND: The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. METHODS/DESIGN: 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect) costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated. DISCUSSION: The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected) infected necrotizing pancreatitis.
- Published
- 2006
16. Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711].
- Author
-
van Brunschot, Sandra, van Grinsven, Janneke, Voermans, Rogier P, Bakker, Olaf J, Besselink, Marc Gh, Boermeester, Marja A, Bollen, Thomas L, Bosscha, Koop, Bouwense, Stefan A, Bruno, Marco J, Cappendijk, Vincent C, Consten, Esther C, Dejong, Cornelis H, Dijkgraaf, Marcel Gw, van Eijck, Casper H, Erkelens, G Willemien, van Goor, Harry, Hadithi, Mohammed, Haveman, Jan-Willem, and Hofker, Sijbrand H
- Abstract
Background: Infected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention. Traditionally, primary open necrosectomy has been the treatment of choice. In recent years, the surgical step-up approach, consisting of percutaneous catheter drainage followed, if necessary, by (minimally invasive) surgical necrosectomy has become the standard of care. A promising minimally invasive alternative is the endoscopic transluminal step-up approach. This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy. We hypothesise that the less invasive endoscopic step-up approach is superior to the surgical step-up approach in terms of clinical and economic outcomes.Methods/design: The TENSION trial is a randomised controlled, parallel-group superiority multicenter trial. Patients with (suspected) infected necrotising pancreatitis with an indication for intervention and in whom both treatment modalities are deemed possible, will be randomised to either an endoscopic transluminal or a surgical step-up approach. During a 4 year study period, 98 patients will be enrolled from 24 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of death and major complications within 6 months following randomisation. Secondary endpoints include complications such as pancreaticocutaneous fistula, exocrine or endocrine pancreatic insufficiency, need for additional radiological, endoscopic or surgical intervention, the need for necrosectomy after drainage, the number of (re-)interventions, quality of life, and total direct and indirect costs.Discussion: The TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications, as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis. [ABSTRACT FROM AUTHOR]- Published
- 2013
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.