par Sherman, Stuart;Cheng, Chi-Liang;Costamagna, Guido;Binmoeller, Kenneth F;Puespoek, Andreas;Aithal, Guruprasad P;Kozarek, Richard;Chen, Yang;Van Steenbergen, Werner;Tenner, Scott;Freeman, Martin;Monroe, Paul;Geffner, Michael;Devière, Jacques ;Interleukin-10 ERCP Study Group,
Référence Pancreas, 38, 3, page (267-274)
Publication Publié, 2009-04
Référence Pancreas, 38, 3, page (267-274)
Publication Publié, 2009-04
Article révisé par les pairs
Résumé : | OBJECTIVES: Pancreatitis 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. METHODS: A 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. RESULTS: A 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. |