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Randomized Controlled Trial
Copyright ©The Author(s) 2026. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Jan 16, 2026; 18(1): 113788
Published online Jan 16, 2026. doi: 10.4253/wjge.v18.i1.113788
Lactated Ringer’s solution in combination with indomethacin for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A prospective, randomized trial
Khellaf Amalou, Nadjib Benboudiaf, Mohamed Tahar Medkour, Farid Belghanem, Hana Chetroub, Ryma Rekab, Ahlem Belloula, Fateh Bouaouina, Khadidja Saidani
Khellaf Amalou, Nadjib Benboudiaf, Mohamed Tahar Medkour, Farid Belghanem, Hana Chetroub, Ryma Rekab, Ahlem Belloula, Fateh Bouaouina, Khadidja Saidani, Department of Gastroenterology, Mohamed Seghir Nekkache, Algiers 16000, Algeria
Author contributions: Amalou K took responsibility in necessary literature review for the study, writing of the whole of the article and review it before submission scientifically besides spelling and grammar; Benboudiaf N, Medkour MT, Belghanem F, Chetroub H, and Bouaouina F analyzed the data and wrote the manuscript; Rekab R, Belloula A, and Saidani K reviewed the article before submission; all authors have and approve the final manuscript.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board.
Clinical trial registration statement: This trial was registered online at the Pan African Clinical Trials Registry (https://pactr.samrc.ac.za/) before the enrollment of any patients, No. PACTR202201712208274.
Informed consent statement: All participants provided informed consent.
Conflict-of-interest statement: All authors declare no conflict of interest in publishing the manuscript.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: No additional data are available.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Khellaf Amalou, PhD, Assistant Professor, Department of Gastroenterology, Mohamed Seghir Nekkache, Kouba 246, Algiers 16000, Algeria. amalou_kh@yahoo.fr
Received: September 4, 2025
Revised: October 29, 2025
Accepted: December 4, 2025
Published online: January 16, 2026
Processing time: 133 Days and 9.8 Hours
Abstract
BACKGROUND

Prospective data have shown the benefit of rectal indomethacin (IND) in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). Recent pilot studies demonstrated a lower incidence of PEP after an 8-hour lactated Ringer’s solution (LR) infusion.

AIM

To assess the efficacy of IND, with or without a bolus of LR, in patients at a high risk for PEP.

METHODS

In this randomized, double-blinded controlled trial, we assigned patients to LR, IND, or LR + IND. Each liter of fluid infusion was completed within 30 minutes. Patients were determined to be high-risk based on established criteria and excluded if they had pancreatitis, contraindications to IND, or signs of volume overload. Our primary outcome was PEP, defined by standardized criterion. Our secondary outcomes were severe acute pancreatitis, localized adverse events, death, length of stay, and readmission.

RESULTS

The study sample included 210 patients (70 per group) who accomplished follow-up at 24 hours and 30 days post-endoscopic retrograde cholangiopancreatography. All patients presented at least one high-risk factor for PEP, with 59% having more than one. PEP was observed in 23 patients (10,9%): Five patients (7%) in the LR + IND group vs twelve patients (17%) in the LR group (P = 0.04) and six patients (8%) in the IND group (P = 0.06). Readmission rates were reduced in the LR + IND group [2 (2%)] vs the LR group [7 (10%); P = 0.03]. No differences were seen among the other study groups. One case of severe acute pancreatitis was reported, with two cases in the LR group and one in the IND group.

CONCLUSION

In high-risk patients for PEP, the combination of LR + IND decreased the incidence of PEP and readmission rates compared to LR or IND administered alone.

Keywords: Lactated Ringer’s solution; Indomethacin; Post-endoscopic retrograde cholangiopancreatography pancreatitis; Efficacy; Outcomes

Core Tip: Endoscopic retrograde cholangiopancreatography is an important technique for the diagnosis and treatment of pancreaticobiliary disorders. Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is the most prevalent complication relating to endoscopic retrograde cholangiopancreatography. Rectal nonsteroidal anti-inflammatory drugs and prophylactic pancreatic stent insertion remain advised for its prevention. The administration of lactated Ringer’s solution (LR) plays an important part in preventing pancreatic necrosis and organ failure by sustaining steady pancreatic microcirculation. This randomized, double-blind, controlled study showed that the infusion of LR combined with rectal indomethacin (IND) may decrease the occurrence of PEP and post-procedure readmission in high-risk patients, compared to LR or IND administered separately.