Use of udenafil is not associated with a reduction in post-ERCP pancreatitis: results of a randomized, placebo-controlled, multicenter trial.
Keywords
Abstract
BACKGROUND
Udenafil, a phosphodiesterase-5 inhibitor, may decrease sphincter of Oddi tone and allow efficient cannulation.
OBJECTIVE
To determine whether prophylactic udenafil reduces the rates of occurrence of post-ERCP pancreatitis.
METHODS
Prospective, randomized, double-blind, placebo-controlled, multicenter study.
METHODS
Three academic medical centers.
METHODS
From November 2008 to November 2010, a total of 278 patients who underwent ERCP were analyzed.
METHODS
ERCP.
METHODS
Rate of post-ERCP pancreatitis.
RESULTS
Demographic features, indications for ERCP, and therapeutic procedures were similar in each group. The overall rate of pancreatitis was 7.9% (22/278). There was no significant difference in the rate (8.0% [11/137] vs 7.8% [11/141], P = .944) and severity of post-ERCP pancreatitis between the udenafil and placebo groups. Severe pancreatitis developed in 1 patient in the placebo group. On both univariate and multivariate analyses, age 40 years or younger, suspected sphincter of Oddi dysfunction, complete pancreatic duct opacification, and failed cannulation were associated with post-ERCP pancreatitis. Only mild udenafil-related complications occurred, including flushing (n = 3) and headache (n = 3).
CONCLUSIONS
Unselected patient group, overestimation of the rate of pancreatitis in the placebo group.
CONCLUSIONS
Udenafil was not effective for prevention of post-ERCP pancreatitis in this study. (
BACKGROUND
KCT0000021.).
