Mo1455 Effect of Udenafil on the Prevention of Post-ERCP Pancreatitis (PEP): Prospective, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study

Mo1455 Effect of Udenafil on the Prevention of Post-ERCP Pancreatitis (PEP): Prospective, Randomized, Double-Blinded, PlaceboControlled, Multicenter Study Hyoung-Chul Oh, Young Koog Cheon, Young Deok Cho, Jae Hyuk Do Gastroenterology, Chung-Ang University College of Medicine, Yongsan Hospital, Seoul, Republic of Korea; Gastroenterology, Soon Chun Hyang University College of Medicine, Seoul, Republic of Korea; Gastroenterology, Chung-Ang University College of Medicine, University Hospital, Seoul, Republic of Korea Background: Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Obstruction of pancreatic outflow may arise from mechanical injury to the papilla and pancreatic sphincter, and pancreatic sphincter hypertension. A recent study showed phosphodiesterase type-5 (PDE-5) inhibitor reduced sphincter of Oddi (SO) motility. PDE-5 inhibitor may decrease SO tone, allow easy cannulation, and reduce the incidence of PEP. Methods: After initial screening, 278 enrolled patients were randomized and stratified by age and sex to Udenafil group (n 137) and Placebo group (n 141). Udenafil (Zydena®, Dong-A Pharmaceutical Co, Korea) or Placebo was given 2h before ERCP and all patients were prospectively evaluated for the development of pancreatitis until 72 h after ERCP. The incidence of PEP and factors associated with PEP were analyzed. Results: Demographic features, indication for ERCP and therapeutic procedures were similar in 2 groups. The overall incidence of pancreatitis was 7.9%. There was no difference in the incidence of PEP (8.0% vs. 7.8%, p .944) and severity between the Udenafil and Placebo groups. One patient in Placebo group developed severe pancreatitis. The incidence of hyperamylasemia was also similar (10.1% in Udenafil vs. 13.6% in placebo, p .451). In high-risk group, there was no significant difference in the incidence of PEP between the Udenafil and Placebo groups. On univariate analysis, age 40 years, suspected SOD and complete pancreatic opacification was associated with PEP. On multivariate analysis, age 40 years, suspected SOD and complete pancreatic opacification were independently associated with PEP. There was only mild udenafil-related complications including flushing (n 3) and headache (n 3). Conclusions: Phosphodiesterase-5 inhibitor, Udenafil, was not effective in the prevention of PEP.