Korean J Intern Med.  2015 Sep;30(5):602-609. 10.3904/kjim.2015.30.5.602.

Oral udenafil and aceclofenac for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients: a randomized multicenter study

Affiliations
  • 1Division of Gastroenterology, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
  • 2Division of Gastroenterology, Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea.
  • 3Division of Gastroenterology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea. ohcgi@cau.ac.kr
  • 4Division of Gastroenterology, Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea.

Abstract

BACKGROUND/AIMS
Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography (ERCP). Combination therapy w ith ora l udenafil and aceclofenac may reduce the occurrence of post-ERCP pancreatitis by targeting different pathophysiological mechanisms. We investigated whether combining udenafil and aceclofenac reduced the rates of post-ERCP pancreatitis.
METHODS
A prospective, randomized, double-blind, placebo-controlled, multicenter study was conducted in four academic medical centers. Between January 2012 and June 2013, a total of 216 patients who underwent ERCP were analyzed for the occurrence of post-ERCP pancreatitis. Patients were determined to be at high risk for pancreatitis based on validated patient and procedure-related risk factors.
RESULTS
Demographic features, indications for ERCP, and therapeutic procedures were similar in each group. There were no significant differences in the rate (15.8% [17/107] vs. 16.5% [18/109], p = 0.901) and severity of post-ERCP pancreatitis between the udenafil/aceclofenac and placebo groups. One patient in each group developed severe pancreatitis. Multivariate analyses indicated that suspected dysfunction of the sphincter of Oddi and endoscopic papillary balloon dilation without sphincterotomy were associated with post-ERCP pancreatitis.
CONCLUSIONS
Combination therapy with udenafil and aceclofenac is not effective for the prevention of post-ERCP pancreatitis.

Keyword

Cholangiopancreatography, endoscopic retrograde; Pancreatitis; Udenafil; Aceclofenac

MeSH Terms

Acute Disease
Administration, Oral
Adult
Aged
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/adverse effects
Cholangiopancreatography, Endoscopic Retrograde/*adverse effects
Diclofenac/administration & dosage/adverse effects/*analogs & derivatives
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Male
Middle Aged
Multivariate Analysis
Pancreatitis/diagnosis/etiology/*prevention & control
Phosphodiesterase 5 Inhibitors/*administration & dosage/adverse effects
Prospective Studies
Pyrimidines/*administration & dosage/adverse effects
Republic of Korea
Risk Factors
Sulfonamides/*administration & dosage/adverse effects
Treatment Outcome
Young Adult
Anti-Inflammatory Agents, Non-Steroidal
Diclofenac
Phosphodiesterase 5 Inhibitors
Pyrimidines
Sulfonamides
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