Efficacy of Recombinant Human Interleukin-10 in Prevention of Acute Pancreatitis After ERCP in Subjects with Increased Risk: Randomized Prospective Multicenter Study

Abstract

Efficacy of Recombinant Human Interleukin-10 in Prevention of Acute Pancreatitis After ERCP in Subjects with Increased Risk: Randomized Prospective Multicenter Study Stuart Sherman, Chi-Liang Chen, Guido Costamagna, Kenneth F. Binmoeller, Andreas Puespoek, Guruprasad P. Aithal, Richard A. Kozarek, Yang K. Chen, Werner Van Steenbergen, Scott Tenner, Martin L. Freeman, Paul Monroe, Michael Geffner, Jacques Deviere Background: Acute pancreatitis is the most common major complication of ERCP occurring in up to 30% of high-risk patients. Interleukin-10 (IL-10) is a potent inhibitor of inflammatory cytokines and has been shown to attenuate pancreatitis in animal models and pilot human studies. The aim of the study was to determine whether prophylactic IL-10 administration reduces the frequency and severity of post-ERCP pancreatitis in high-risk patients. Methods: This is a randomized multicenter, double-blind, placebo-controlled study. Patients received IL-10 at a dose of either 8 or 20 mcg/kg or received placebo as a single intravenous injection 15 to 30 minutes prior to ERCP. The definition of post-ERCP acute pancreatitis and the grading of its severity were based on consensus criteria. Results: See table. Patient demographics and the incidence of patient and procedure risk factors for pancreatitis were similar in all treatment groups. Due to the apparent lack of efficacy, the study was terminated after a total of 305 patients were randomized (planned enrollment was 948 patients). The frequency of adverse events was similar among the three groups.