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] |
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Authors: | Marc GH Besselink Hjalmar C van Santvoort Vincent B Nieuwenhuijs Marja A Boermeester Thomas L Bollen Erik Buskens Cornelis HC Dejong Casper HJ van Eijck Harry van Goor Sijbrand S Hofker Johan S Lameris Maarten S van Leeuwen Rutger J Ploeg Bert van Ramshorst Alexander FM Schaapherder Miguel A Cuesta Esther CJ Consten Dirk J Gouma Erwin van der Harst Eric J Hesselink Lex PJ Houdijk Tom M Karsten Cees JHM van Laarhoven Jean-Pierre EN Pierie Camiel Rosman Ernst Jan Spillenaar Bilgen Robin Timmer Ingeborg van der Tweel Ralph J de Wit Ben JM Witteman Hein G Gooszen |
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Affiliation: | 1. Department of Surgery, University Medical Center Utrecht, The Netherlands 2. Department of Surgery, Academic Medical Center Amsterdam, The Netherlands 3. Department of Radiology, St. Antonius Hospital Nieuwegein, The Netherlands 4. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands 5. Department of Surgery, University Hospital Maastricht and NUTRIM institute, The Netherlands 6. Department of Surgery, Erasmus Medical Center Rotterdam, The Netherlands 7. Department of Surgery, Radboud University Nijmegen Medical Centre, The Netherlands 8. Department of Surgery, University Medical Center Groningen, The Netherlands 9. Department of Radiology, Academic Medical Center Amsterdam, The Netherlands 10. Department of Surgery, St. Antonius Hospital Nieuwegein, The Netherlands 11. Department of Surgery, Leiden University Medical Center, The Netherlands 12. Department of Surgery, VU Medical Center Amsterdam, The Netherlands 13. Department of Surgery, Meander Medical Center Amersfoort, The Netherlands 14. Department of Surgery, Medical Center Rijnmond Zuid Rotterdam, The Netherlands 15. Department of Surgery, Gelre Hospitals Apeldoorn, The Netherlands 16. Department of Surgery, Medical Center Alkmaar, The Netherlands 17. Department of Surgery, Reinier de Graaf Group Delft, The Netherlands 18. Department of Surgery, St. Elisabeth Hospital Tilburg, The Netherlands 19. Department of Surgery, Medical Center Leeuwarden, The Netherlands 20. Department of Surgery, Canisius Wilhelmina Hospital Nijmegen, The Netherlands 21. Department of Surgery, Rijnstate Hospital Arnhem, The Netherlands 22. Department of Gastroenterology, St. Antonius Hospital Nieuwegein, The Netherlands 23. Utrecht University, Centre for Biostatistics, The Netherlands 24. Department of Surgery, Medical Spectrum Twente, Enschede, The Netherlands 25. Department of Gastroenterology and Hepatology, Gelderse Vallei Ede, The Netherlands
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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. |
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