title: Efficacy of recombinant human interleukin-10 in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in subjects with increased risk.
abstract: OBJECTIVE
  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.
authors.affiliation: Division of Gastroenterology/Hepatology, Indiana University Medical Center, Indianapolis, IN 46202, USA. ssherman@iupui.edu
authors.forename: Stuart
authors.initials: S
authors.lastname: Sherman
authors.forename: Chi-Liang
authors.initials: CL
authors.lastname: Cheng
authors.forename: Guido
authors.initials: G
authors.lastname: Costamagna
authors.forename: Kenneth F
authors.initials: KF
authors.lastname: Binmoeller
authors.forename: Andreas
authors.initials: A
authors.lastname: Puespoek
authors.forename: Guruprasad P
authors.initials: GP
authors.lastname: Aithal
authors.forename: Richard A
authors.initials: RA
authors.lastname: Kozarek
authors.forename: Yang K
authors.initials: YK
authors.lastname: Chen
authors.forename: Werner
authors.initials: W
authors.lastname: Van Steenbergen
authors.forename: Scott
authors.initials: S
authors.lastname: Tenner
authors.forename: Martin
authors.initials: M
authors.lastname: Freeman
authors.forename: Paul
authors.initials: P
authors.lastname: Monroe
authors.forename: Michael
authors.initials: M
authors.lastname: Geffner
authors.forename: Jacques
authors.initials: J
authors.lastname: Deviere
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects* / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D015994:Incidence; D007275:Injections, Intravenous; D016753:Interleukin-10 / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control*; D010919:Placebos; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012307:Risk Factors; D017211:Treatment Failure
chemical_list: D010919:Placebos; D011994:Recombinant Proteins; D016753:Interleukin-10