title: Use of udenafil is not associated with a reduction in post-ERCP pancreatitis: results of a randomized, placebo-controlled, multicenter trial.
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.).
authors.affiliation: Division of Gastroenterology, Chung-Ang University College of Medicine, Seoul, Korea.
authors.forename: Hyoung-Chul
authors.initials: HC
authors.lastname: Oh
authors.forename: Young Koog
authors.initials: YK
authors.lastname: Cheon
authors.forename: Young Deok
authors.initials: YD
authors.lastname: Cho
authors.forename: Jae Hyuk
authors.initials: JH
authors.lastname: Do
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects; D004311:Double-Blind Method; D006801:Humans; D016015:Logistic Models; D008875:Middle Aged; D015999:Multivariate Analysis; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D058986:Phosphodiesterase 5 Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors; D012720:Severity of Illness Index; D046628:Sphincter of Oddi Dysfunction / Q000150:complications; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult; D000096926:Benzenesulfonamides
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; C419664:udenafil; D000096926:Benzenesulfonamides