Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): Study protocol for a randomized controlled trial
Schepers, Nicolien J.; Bakker, Olaf J.; Besselink, Marc G H; Bollen, Thomas L.; Dijkgraaf, Marcel G W; van Eijck, Casper H J; Fockens, Paul; van Geenen, Erwin J M; van Grinsven, Janneke; Hallensleben, Nora D L; Hansen, Bettina E.; van Santvoort, Hjalmar C.; Timmer, Robin; Anten, Marie Paule G F; Bolwerk, Clemens J M; van Delft, Foke; van Dullemen, Hendrik M.; Erkelens, G. Willemien; van Hooft, Jeanin E.; Laheij, Robert; van der Hulst, René W M; Jansen, Jeroen M.; Kubben, Frank J G M; Kuiken, Sjoerd D.; Perk, Lars E.; de Ridder, Rogier J J; Rijk, Marno C M; Römkens, Tessa E H; Schoon, Erik J.; Schwartz, Matthijs P.; Spanier, B. W Marcel; Tan, Adriaan C I T L; Thijs, Willem J.; Venneman, Niels G.; Vleggaar, Frank P.; van de Vrie, Wim; Witteman, Ben J.; Gooszen, Hein G.; Bruno, Marco J.
(2016) Trials [E], volume 17
(Article)
Abstract
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
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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)
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Keywords: Acute pancreatitis, Endoscopy, ERC, ERCP, Pancreas, Treatment, Medicine (miscellaneous), Pharmacology (medical), Journal Article, Research Support, Non-U.S. Gov't, Comparative Study, Multicenter Study, Randomized Controlled Trial
ISSN: 1745-6215
Publisher: BioMed Central
(Peer reviewed)