Comparison between ulinastatin and nafamostat for prevention of post-endoscopic retrograde cholangiopancreatography complications: a prospective, randomized trial

Abstract

Objectives: Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The aim of this prospective trial was to compare the effect of ulinastatin and nafamostat on the prophylaxis of post-ERCP complications.

Methods: A total of 159 patients who underwent ERCP were divided into ulinastatin (n = 53), nafamostat (n = 53) and control (n = 53) groups. Each patient received ulinastatin (150,000 units), nafamostat (20 mg), or placebo from 2-4 h before ERCP to 6-8 h after ERCP. The primary endpoint was the incidence of PEP, and the secondary endpoints were the incidence of post-ERCP hyperamylasemia, hyperlipasemia and abdominal pain.

Results: The overall incidence of PEP was 6.3% (10/159) and no significant differences were observed between ulinastatin and nafamostat groups in terms of the incidences of PEP (1.9% and 3.8%, P = 0.560), hyperamylasemia, hyperlipasemia, and abdominal pain, although these were significantly lower than those of the control group (P < 0.001).

Conclusions: There was no significant difference for preventing PEP between ulinastatin and nafamostat and both drugs were efficacious for preventing post-ERCP complications.

Keywords: Endoscopic retrograde cholangiopancreatography; Nafamostat; Pancreatitis; Post-endoscopic retrograde cholangiopancreatography complications; Post-endoscopic retrograde cholangiopancreatography pancreatitis; Ulinastatin.