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
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.