Efficacy of recombinant human interleukin-10 in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in subjects with increased risk.
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.
Sherman
Stuart
S
Division of Gastroenterology/Hepatology, Indiana University Medical Center, Indianapolis, IN 46202, USA. ssherman@iupui.edu
Cheng
Chi-Liang
CL
Costamagna
Guido
G
Binmoeller
Kenneth F
KF
Puespoek
Andreas
A
Aithal
Guruprasad P
GP
Kozarek
Richard A
RA
Chen
Yang K
YK
Van Steenbergen
Werner
W
Tenner
Scott
S
Freeman
Martin
M
Monroe
Paul
P
Geffner
Michael
M
Deviere
Jacques
J
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
D010919:Placebos; D011994:Recombinant Proteins; D016753:Interleukin-10