Study on administration timing and combination therapy of NSAIDs for preventing post-ERCP pancreatitis

Abstract

Objective: To determine the optimal timing, dosage, and efficacy of combination NSAID therapy in preventing post-ERCP pancreatitis.

Methods: A total of 866 patients undergoing ERCP between December 2021 and December 2023 were enrolled and randomly assigned to an observation group or a control group, with further subgrouping into combination therapy or monotherapy groups. The observation group received NSAIDs such as indomethacin suppositories and/or diclofenac sodium before ERCP, while the control group received NSAIDs postoperatively. The combination therapy group received both diclofenac sodium and indomethacin suppositories, whereas the monotherapy group received only diclofenac sodium. Primary endpoints included the incidence and severity of pancreatitis, as well as the occurrence of post-procedural complications such as perforation, bleeding, cholangitis, and pain scores. These outcomes were compared between groups to evaluate differences in the incidence and severity of PEP.

Results: The group receiving pre-procedural NSAIDs had a significantly lower risk of adverse reactions compared with the post-procedural group. Combination therapy showed superior PEP risk reduction compared to monotherapy. Independent risk factors for PEP included female sex, age > 60 years, a history of gallstones or pancreatitis, hypertension, five cannulation attempts > 5, and non-dilated extrahepatic bile ducts.

Conclusion: Prophylactic combination therapy with indomethacin suppositories and diclofenac sodium before ERCP significantly reduces PEP incidence and severity, while concurrently decreasing risks of perforation, hemorrhage, cholangitis, and postoperative pain scores.

Keywords

ERCP / Pancreatitis / Adverse reactions / Indomethacin suppository / Diclofenac sodium

Declarations

Not applicable.

Authors' contributions

X. Wu: Conceptualization, Methodology, Project Administration, Resources. W. Cui: Data Curation, Writing - Original Draft, Writing - Review & Editing. X. Wu: Formal Analysis, Supervision. E. Li: Investigation, Validation. H. Wang: Data Curation, Investigation. W. Qi: Data Curation, Formal Analysis. X. Li: Methodology, Formal Analysis, Validation. S. Hou: Supervision, Project Administration.

Ethics approval and consent to participate

The study was approved by the Medical Ethics Committee of Handan Central Hospital (Approval No.: [2024] Ethics Review Paper No. (020)). All procedures involving human participants were conducted in accordance with the ethical standards set by the institutional and national research committees and with the 1964 Helsinki Declaration and its subsequent amendments or comparable ethical standards. Informed consent was obtained from all participants before participation in the study.

Consent for publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

This research was supported by the Key Research and Development Program of Hebei Province (22377734D) and the Science and Technology Research and Development Program of Handan City (21422083149).

Declaration of Competing Interest

The authors declare that they have no competing interests.

Acknowledgements

Not applicable.

Authors' other information

Not applicable.

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