Efficacy of Ulinastatin in Preventing Post-ERCP Pancreatitis in High-Risk Patients: A Prospective Cohort Study

Abstract Pancreatitis is a frequent aftermath of endoscopic retrograde cholangiopancreatography (ERCP), often associated with local and systemic complications that subsequently prolong hospitalization. Despite pharmacological and technical modalities for prophylaxis, there is still an unmet need for novel preventive measures. So, this prospective cohort study was conducted to evaluate whether ulinastatin administration prevents post-ERCP pancreatitis in high-risk scenarios. A total of 272 patients were screened for inclusion. Finally, 172 patients were recruited. Eighty-six patients were considered to have a high risk of post-ERCP pancreatitis based on demographic and intervention-related factors. They constituted the “treatment group” and received 1 lac unit intravenous ulinastatin and standard prophylactic measures. Rest served as the “control group” and received standard care only. Incidence of pancreatitis, hyperenzymemia, pain on day 1 of the procedure, hospital expenditure, and length of hospitalization were compared. Post-ERCP pancreatitis and hyperenzymemia incidence was significantly lower in the “treatment group” (2.70% vs. 11.62%, p = 0.016; 11.63% vs. 29.07%, p = 0.004). Likewise, postprocedure pain on the visual analog scale was less in the “treatment group” (2.97 ± 0.29 vs. 3.36 ± 0.77, p < 0.001). Ulinastatin recipients had a significantly shorter hospital stay (27.57 ± 11.01 vs. 35.35 ± 21.84 hours, p = 0.007) and lesser expenditure (p = 0.039). On univariate and multivariate analysis, ulinastatin administration was associated with lower risk of post-ERCP pancreatitis: 0.181 (confidence interval [CI]: 0.038–0.852; p-value 0.031) and 0.181 (CI: 0.038–0.871; p-value 0.033), respectively. Short-term ulinastatin administration was associated with reduced incidence of post-ERCP pancreatitis in high-risk patients.