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.