Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial

Abstract

BackgroundAcute 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/DesignThe 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.DiscussionThe 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 registrationCurrent Controlled Trials ISRCTN97372133 (date registration: 17-12-2012)Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1132-0) contains supplementary material, which is available to authorized users.

Acute pancreatitis: recent advances through randomised trials

“…Recently, a multicentre RCT* comparing routine early ERC plus ES with conservative treatment in 232 patients with predicted severe acute biliary pancreatitis but without cholangitis was completed and results are awaited (the APEC-trial, ISRCTN97372133). 70…”

<p>The Clinical Characteristics of Acute Pancreatitis in Gerontal Patients: A Retrospective Study</p>

“…AP is an acute disease, and the incidence rate increases proportionally with age. 24 Data from an emergency department (ED) showed that ageing patients aged over 65 years old diagnosed with AP comprised one-third of all patients. 8 Another registry study reported a six-fold increase in the incidence of AP patients aged over 80 years over a decade.…”

Managing Infected Pancreatic Necrosis

“…Some authors have advocated early ERCP intervention in all patients with (predicted) severe biliary pancreatitis (61,62), however this has not become standard of care (10,47). The multicentre APEC trial is currently studying the impact of routine early (<24 hours) ERCP in predicted severe biliary pancreatitis (63). There is consensus that patients with mild and moderate AP do not require early ERCP (62), as potential benefits do not outweigh the procedural risks.…”