• Stuart Sherman, Chi-Liang Cheng, Guido Costamagna, Kenneth F Binmoeller, Andreas Puespoek, Guruprasad P Aithal, Richard A Kozarek, Yang K Chen, Werner Van Steenbergen, Scott Tenner, Martin Freeman, Paul Monroe, Michael Geffner, Jacques Deviere, and Interleukin-10 ERCP Study Group.
• Division of Gastroenterology/Hepatology, Indiana University Medical Center, Indianapolis, IN 46202, USA. ssherman@iupui.edu
• Pancreas. 2009 Apr 1; 38 (3): 267-74.

ObjectivesPancreatitis is the most common major complication of endoscopic retrograde cholangiopancreatography (ERCP). Inflammatory cytokines are released during acute pancreatitis. Interleukin-10 (IL-10) is a potent inhibitor of cytokines and has been shown to attenuate pancreatitis in animal models and pilot human studies. This study aimed to determine whether prophylactic IL-10 administration reduces the frequency and/or severity of post-ERCP pancreatitis in high-risk patients.MethodsA randomized, multicenter, double-blind, placebo-controlled study was conducted. Patients received IL-10 at a dose of either 8 or 20 microg/kg or placebo as a single intravenous injection 15 to 30 minutes before ERCP. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis.ResultsA total of 305 of the planned total enrollment of 948 patients were randomized. There was a 15%, 22%, and 14% incidence of post-ERCP pancreatitis in the IL-10 (8 microg/kg), IL-10 (20 microg/kg), and placebo treatment groups, respectively (P = 0.83 for IL-10 8 microg/kg vs placebo and 0.14 for IL-10 20 microg/kg vs placebo). Due to apparent lack of efficacy, the study was terminated at an interim analysis.Conclusions: There was no apparent benefit of IL-10 treatment when compared with placebo in reducing the incidence of post-ERCP acute pancreatitis in subjects with increased risk.

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