Indomethacin prevents post-ERCP pancreatitis in selected high-risk patients

Abstract

BackgroundPancreatitis is one of the major complications of cholan-giopancreatography (ERCP). It occurs in 1–10 % ofpatients but the incidence may reach 25 % in high-riskpatient populations. Generally post-ERCP pancreatitis(PEP) is mild, but moderate or severe pancreatitis (pan-creas necrosis, pseudocyst formation, need of surgicalintervention, long hospitalization) may arise in 0.5 % ofcases [1, 2].The most common risk factors for this complication areboth patient-related and procedure-related: younger age,female gender, prior ERCP-induced pancreatitis, sphincterof Oddi dysfunction, pancreas divisum, difficulty of can-nulation, biliary sphincterotomy or pancreatic opacification[3]. Although some randomized clinical trials (RCTs) haveshown a potential benefit of gabexate mesilate andsomatostatin in preventing post-ERCP pancreatitis, thereare few data to recommend the use of these drugs; more-over, they require continuous infusion and are quiteexpensive [4, 5].A few RCTs have demonstrated a potential role ofnonsteroidal anti-inflammatory drugs (NSAIDs) as pre-vention for post-ERCP pancreatitis, but before introducingthese prophylactic strategies in clinical practice, morestudies are needed [6, 7].SummaryElmunzer et al. conducted a multicenter, randomized,placebo-controlled, double-blind clinical trial comparingthe use of a single dose of rectal indomethacin versusplacebo for the prevention of post-ERCP pancreatitis inhigh-risk patients. Patients were considered eligible, if theymet at least one major criteria: (clinical suspicion ofsphincter of Oddi dysfunction, a history of PEP, pancreaticsphincterectomy, precut sphincterectomy, more than eightcannulation attempts, pneumatic dilatation of an intactbiliary sphincter or ampullectomy) or two or more minorcriteria (age less than 50 and female gender, a history ofrecurrent pancreatitis, three or more injections of contrastagent into the pancreatic duct, excessive injection of con-trast agent resulting in opacification of pancreatic acini, orthe acquisition of a cytologic specimen from the pancreaticduct using a brush). The main exclusion criteria were:active pancreatitis, contraindication to the use of NSAIDs(creatinine level [1.4 mg per deciliter, or active pepticulcer disease), pre-existing therapy with NSAIDs (exceptfor cardioprotective aspirin), and low risk of post procedurepancreatitis (chronic calcific pancreatitis, biliary stentexchange). After ERCP had been performed, a total of 602patients were randomized to receive either 100 mg of rectalindomethacin or a placebo immediately after the proce-dure. The primary outcome was the development of PEPdefined as new-onset upper abdominal pain associated withan elevation of pancreatic enzymes C3 URL, and hospi-talization for at least two nights. The secondary outcomewas the development of moderate or severe post-ERCPpancreatitis. Patients who were discharged after anuneventful procedure were contacted by telephone after5 days, and again after 30 days to assess for delayedadverse events, and to determine the severity of post-ERCP