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CC BY 4.0 · Journal of Digestive Endoscopy
DOI: 10.1055/s-0045-1809612
Research Article

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

Sandip Pal 
1   Department of Gastroenterology, Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, West Bengal, India
,
Gourab Bhaduri
1   Department of Gastroenterology, Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, West Bengal, India
,
Srikant Mohta 
1   Department of Gastroenterology, Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, West Bengal, India
,
Sauren Panja
2   Department of Medicine, Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, West Bengal, India
,
Srinath Mahankali
2   Department of Medicine, Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, West Bengal, India
,
N. P. Bohidar
1   Department of Gastroenterology, Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, West Bengal, India
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Abstract

Objective

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.

Materials and Methods

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.

Results

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.

Conclusion

Short-term ulinastatin administration was associated with reduced incidence of post-ERCP pancreatitis in high-risk patients.

Keywords

hyperenzymemia - post-ERCP pancreatitis - ulinastatin

Authors' Contributions

• S.P.: Performed ERCPs, guided the entire research work regarding the collection of data, and finalized the manuscript with modifications.


• G.B.: Writing of manuscript and statistical analysis.


• S.M.: Guided writing of manuscript and statistical analysis.


• S.P.: Collection of data and writing of the manuscript.


• S.M.: Collection of data.


• N.P.B.: Performed ERCPs.




Publication History

Article published online:
13 June 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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