Nafamostat mesylate in the prevention of post-ERCP pancreatitis and risk factors for post-ERCP pancreatitis

Background Pancreatitis is a major complication of ERCP. Objective To determine whether nafamostat mesylate prophylaxis decreases the incidence of post-ERCP pancreatitis (PEP). Design A single-center, randomized, double-blinded, controlled trial. Setting A large tertiary-referral center. Patients From January 2005 to December 2007, a total of 704 patients who underwent ERCP were analyzed. Intervention Patients received continuous infusion of 500 mL of 5% dextrose solution with 20 mg of nafamostat mesylate (354 patients) or without 20 mg of nafamostat mesylate (350 patients). Serum amylase and lipase levels were checked before ERCP, 4 and 24 hours after ERCP, and when clinically indicated. Main Outcome Measurements The incidence of PEP and risk factors associated with the development of PEP. Results The incidence of acute pancreatitis was 5.4%. There was a significant difference in the incidence of PEP between the nafamostat mesylate and control groups (3.3% vs 7.4%, respectively; P = .018). Univariate analysis identified history of acute pancreatitis ( P < .001), difficult cannulation ( P = .023), periampullary diverticulum ( P = .004), age younger than 40 years ( P = .009), and ≥5 pancreatic-duct contrast injections (odds ratio [OR] 2.736, P = .012) as statistically significant risk factors. Limitations A single-center study. Conclusions Nafamostat mesylate prophylaxis is partially effective in preventing post-ERCP pancreatitis. Independent risk factors for PEP are a history of acute pancreatitis and multiple pancreatic-duct contrast injections.