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

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.

Post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review for prevention and treatment

“…They found no significant difference between rates of PEP incidence of two groups, indicating udenafil had no prophylactic impact on PEP. Lee et al[109] performed a prospective, randomized, double-blind, placebo-controlled, multicenter RCT to investigate the efficacy of a combination of a high dose of udenafil (PDE-5 inhibitor) and aceclofenac (NSAID) on development of PEP in high-risk patients. Their rationale for this study depended on the potential of the combination to decrease the pressure of the sphincter of Oddi and inflammation in acute pancreatitis through modulation of the cytokine cascade.…”

Post-ERCP Pancreatitis: Prevention, Diagnosis and Management

“…In addition to rectal suppositories, other routes of administration have also been studied. Oral diclofenac [30,31], celecoxib [32] or a combination of udenafil and aceclofenac [33] have not been found to reduce PEP compared to a placebo or saline infusion. Placebocontrolled studies have also found no significant difference in PEP rates with intravenous valdecoxib [34], or with the combination of intramuscular diclofenac and isotonic saline [35].…”

Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis with rectal non-steroidal anti-inflammatory drugs

“…Oral (two doses given 6 hours apart) [32,33] and intramuscular administration [34] of diclofenac have not shown a protective effect on PEP. Why are these methods of administration not effective in PEP prevention when the bioavailability is more than 90% in both instances?…”