A randomized control study to investigate the application of Ulinastatin-containing contrast medium to prevent post-ERCP pancreatitis.

Ulinastatin was reported has positive effects on preventing post-ERCP pancreatitis and hyperamylasemia for patients in average risk. To observe the incidence of post-ERCP pancreatitis and investigate the efficacy and feasibility of using Ulinaststin to prevent post-ERCP pancreatitis.A total of 280 patients were randomized into two arms: an experimental arm using Ulinastatin-containing contrast medium and a control arm using the same contrast medium without Ulinastatin. Blood amylase and urine amylase-2 were measured at three and twenty-four hours after ERCP procedure.There were distinct differences in the incidence of post-ERCP pancreatitis and average blood amylase levels in the two arms (p < 0.05). Post-ERCP pancreatitis was observed in 20 patients (7.1%), including 7 (4.37%) patients in the experimental arm, and 13 (10.83%) patients in control arm. After 3 hours of the operation, the average blood amylase levels in control and experimental arm were 224.82±34.27 U/L and 189.52±20.94 U/L, respectively. Correspondingly, the levels were 233.59±35.05 U/L and 187.09±23.14 U/L after 24 hours. But the difference was not statistically significant in urine amylase-2 levels, hemoleukocyte count and operation time.The exploitation of Ulinastatin in ERCP could decrease the incidence but could not completely prevent the development of post-ERCP pancreatitis.