Objective: Infusion of the protease inhibitor nafamostat mesilate (20 mg) effectively prevents post-ERCP pancreatitis, but only in low-risk groups. This study was performed to evaluate the use of high-dose nafamostat mesilate (50 mg) for prevention of post-ERCP pancreatitis (PEP), especially in high-risk groups.
Methods: A total of 608 patients who underwent ERCP were included; 13 patients were excluded. Patients were divided into 3 groups: controls (group A), infusion with 20 mg of nafamostat mesilate (group B), or infusion with 50 mg of nafamostat mesilate (group C). The incidence of PEP was analyzed.
Results: The overall incidence of acute pancreatitis was 7.4% (44/595). There was a significant difference in the incidence of PEP with or without nafamostat mesilate (13.0% vs 4.0% and 5.1%, respectively; P < 0.0001). Subgroup analysis showed that in low-risk patients, the rate of PEP was significantly different with nafamostat (11.9% vs 2.7% and 4.0%, respectively; P = 0.007). In high-risk patients, the rate of PEP was not significantly different among treatment groups (14.6% vs 5.9% vs 6.9%, respectively; P = 0.108).
Conclusions: Nafamostat mesilate prophylaxis (20 or 50 mg) is effective in preventing post-ERCP pancreatitis. However, the preventive effect of high-dose nafamostat mesilate (50 mg) is not significant in high-risk patients.