A Randomized Comparative Study of 24- and 6-Hour Infusion of Nafamostat Mesilate for the Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Prospective Randomized Comparison Trial.

Abstract

Although prolonged intravenous infusion (24 hours) of nafamostat mesilate is effective for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, it requires hospitalization and is expensive. The aim of this study was to compare the efficacy of 24- versus 6-hour intravenous infusion of 20 mg nafamostat mesilate for the prevention of post-ERCP pancreatitis (PEP). A total of 382 patients who underwent ERCP were randomly assigned into 2 groups: 24 hours or 6 hours. In both groups, nafamostat mesilate (20 mg) infusion was initiated up to an hour before ERCP and continued for either 24 or 6 hours. The overall incidence of pancreatitis was 2.4% (9/371). The rates of PEP following 24- and 6-hour infusion were 2.8% (5/179) and 2.1% (4/192), respectively (P = 0.744). No significant difference was observed in the severity of pancreatitis between the groups. On multivariate analysis, increasing pancreatic duct cannulations (odds ratio, 1.685; 95% confidence interval, 1.036-2.741; P = 0.036) was identified as a statistically significant risk factor of PEP. No difference was found in the incidence of PEP regardless of the duration of nafamostat mesilate infusion. Therefore, 6-hour infusion of 20 mg nafamostat mesilate may be useful for the prevention of PEP in an outpatient setting.