Oral udenafil and aceclofenac for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients: a randomized multicenter study.
OBJECTIVE
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.
Division of Gastroenterology, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
Tae Yoon
TY
Lee
Division of Gastroenterology, Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea.
Jung Sik
JS
Choi
Division of Gastroenterology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Hyoung-Chul
HC
Oh
Division of Gastroenterology, Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea.
Tae Jun
TJ
Song
Division of Gastroenterology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Jae Hyuk
JH
Do
Division of Gastroenterology, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
Young Koog
YK
Cheon
D000208:Acute Disease; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010195:Pancreatitis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage* / Q000009:adverse effects; D056910:Republic of Korea; D012307:Risk Factors; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult; D000096926:Benzenesulfonamides
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; D058986:Phosphodiesterase 5 Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; C419664:udenafil; D000096926:Benzenesulfonamides; C056498:aceclofenac
Aceclofenac; Cholangiopancreatography, endoscopic retrograde; Pancreatitis; Udenafil