Robert J.F. Laheij, Niels G. Venneman, Adriaan C.I.T.L. Tan, Tessa E H Römkens, B W Marcel Spanier, Rogier de Ridder, Casper H.J. van Eijck, Clemens J.M. Bolwerk, Erwin J M van Geenen, Nicolien J. Schepers, G. Willemien Erkelens, Olaf J. Bakker, Bettina E. Hansen, Willem J. Thijs, Thomas L. Bollen, Jeanin E. van Hooft, Janneke van Grinsven, Foke van Delft, Marc G. Besselink, Marie Paule Anten, Marco J. Bruno, Hendrik M. van Dullemen, Ben J.M. Witteman, Robin Timmer, Paul Fockens, Nora D L Hallensleben, Erik J. Schoon, Hjalmar C. van Santvoort, Jeroen M. Jansen, Hein G. Gooszen, René W M van der Hulst, Lars E. Perk, Marcel G. W. Dijkgraaf, Matthijs P. Schwartz, Wim van de Vrie, Frank P. Vleggaar, Frank J G M Kubben, Sjoerd D. Kuiken, Marno C.M. Rijk, Center for Liver, Digestive and Metabolic Diseases (CLDM), RS: NUTRIM - R2 - Gut-liver homeostasis, Interne Geneeskunde, MUMC+: MA Maag Darm Lever (9), Gastroenterology & Hepatology, Surgery, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA -Cancer Center Amsterdam, Clinical Research Unit, Gastroenterology and Hepatology, Graduate School, 02 Surgical specialisms, Other departments, Gastroenterology and hepatology, and AGEM - Digestive immunity
Background Acute pancreatitis is mostly caused by gallstones or sludge. Early decompression of the biliary tree by endoscopic retrograde cholangiography (ERC) with sphincterotomy may improve outcome in these patients. Whereas current guidelines recommend early ERC in patients with concomitant cholangitis, early ERC is not recommended in patients with mild biliary pancreatitis. Evidence on the role of routine early ERC with endoscopic sphincterotomy in patients without cholangitis but with biliary pancreatitis at high risk for complications is lacking. We hypothesize that early ERC with sphincterotomy improves outcome in these patients. Methods/Design The APEC trial is a randomized controlled, parallel group, superiority multicenter trial. Within 24 hours after presentation to the emergency department, patients with biliary pancreatitis without cholangitis and at high risk for complications, based on an Acute Physiology and Chronic Health Evaluation (APACHE-II) score of 8 or greater, Modified Glasgow score of 3 or greater, or serum C-reactive protein above 150 mg/L, will be randomized. In 27 hospitals of the Dutch Pancreatitis Study Group, 232 patients will be allocated to early ERC with sphincterotomy or to conservative treatment. The primary endpoint is a composite of major complications (that is, organ failure, pancreatic necrosis, pneumonia, bacteremia, cholangitis, pancreatic endocrine, or exocrine insufficiency) or death within 180 days after randomization. Secondary endpoints include ERC-related complications, infected necrotizing pancreatitis, length of hospital stay and an economical evaluation. Discussion The APEC trial investigates whether an early ERC with sphincterotomy reduces the composite endpoint of major complications or death compared with conservative treatment in patients with biliary pancreatitis at high risk of complications. Trial registration Current Controlled Trials ISRCTN97372133 (date registration: 17-12-2012) Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-1132-0) contains supplementary material, which is available to authorized users.