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. DESIGN: Prospective, randomized, double-blind, placebo-controlled, multicenter study. SETTING: Three academic medical centers. PATIENTS: From November 2008 to November 2010, a total of 278 patients who underwent ERCP were analyzed. INTERVENTION: ERCP. MAIN OUTCOME MEASUREMENT: 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). LIMITATIONS: Unselected patient group, overestimation of the rate of pancreatitis in the placebo group. CONCLUSION: Udenafil was not effective for prevention of post-ERCP pancreatitis in this study. ( CLINICAL TRIAL REGISTRATION NUMBER: KCT0000021.).
RCT Entities:
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. DESIGN: Prospective, randomized, double-blind, placebo-controlled, multicenter study. SETTING: Three academic medical centers. PATIENTS: From November 2008 to November 2010, a total of 278 patients who underwent ERCP were analyzed. INTERVENTION: ERCP. MAIN OUTCOME MEASUREMENT: 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). LIMITATIONS: Unselected patient group, overestimation of the rate of pancreatitis in the placebo group. CONCLUSION:Udenafil was not effective for prevention of post-ERCP pancreatitis in this study. ( CLINICAL TRIAL REGISTRATION NUMBER: KCT0000021.).