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.
RCT Entities:
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.
Authors: Fariborz Mansour-Ghanaei; Farahnaz Joukar; Ali Akbar Khalesi; Mohammadreza Naghipour; Masood Sepehrimanesh; Kourosh Mojtahedi; Sara Yeganeh; Hamid Saeidi Saedi; Saba Fakhrieh Asl Journal: Ann Hepatobiliary Pancreat Surg Date: 2020-08-31