TY - JOUR
T1 - Efficacy of recombinant human interleukin-10 in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in subjects with increased risk
AU - Sherman, Stuart
AU - Cheng, Chi Liang
AU - Costamagna, Guido
AU - Binmoeller, Kenneth F.
AU - Puespoek, Andreas
AU - Aithal, Guruprasad P.
AU - Kozarek, Richard A.
AU - Chen, Yang K.
AU - Van Steenbergen, Werner
AU - Tenner, Scott
AU - Freeman, Martin
AU - Monroe, Paul
AU - Geffner, Michael
AU - Deviere, Jacques
PY - 2009/4
Y1 - 2009/4
N2 - 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 μg/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 μg/kg), IL-10 (20 μg/kg), and placebo treatment groups, respectively (P = 0.83 for IL-10 8 μg/kg vs placebo and 0.14 for IL-10 20 μg/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.
AB - 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 μg/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 μg/kg), IL-10 (20 μg/kg), and placebo treatment groups, respectively (P = 0.83 for IL-10 8 μg/kg vs placebo and 0.14 for IL-10 20 μg/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.
KW - Interleukin-10
KW - Post-ERCP pancreatitis
UR - https://www.scopus.com/pages/publications/65549121589
UR - https://www.scopus.com/pages/publications/65549121589#tab=citedBy
U2 - 10.1097/MPA.0b013e31819777d5
DO - 10.1097/MPA.0b013e31819777d5
M3 - Article
C2 - 19214137
AN - SCOPUS:65549121589
SN - 0885-3177
VL - 38
SP - 267
EP - 274
JO - Pancreas
JF - Pancreas
IS - 3
ER -