Prophylaxis Against Post-Endoscopic Retrograde Cholangio-Pancreatography Pancreatitis. (Post-ERCP)

May 14, 2026 updated by: Carlos R. Cervantes Sanchez, Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo

Efficacy of Rectal Indomethacin Plus Aggressive Hydration as Prophylaxis to Prevent Post-ERCP Pancreatitis at a Secondary-Care Teaching Hospital: A Randomized Controlled Trial.

Endoscopic retrograde cholangiopancreatography (ERCP) is a key procedure for managing biliopancreatic diseases, although it is associated with complications such as post-ERCP pancreatitis. This study assessed the efficacy of a prophylactic protocol combining rectal indomethacin with aggressive hydration to reduce the incidence of post-ERCP pancreatitis and serum amylase and lipase levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial was conducted with 60 patients undergoing ERCP at a secondary-care teaching public hospital. Patients were divided into two groups: With and without prophylaxis. Differences in post-ERCP pancreatitis incidence and pancreatic enzyme levels before and after the procedure were analyzed.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Chihuahua
      • Chihuahua City, Chihuahua, Mexico, 31000
        • Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who required ERCP
  • Without contraindications to the use of indomethacin or aggressive hydration

Exclusion Criteria:

  • Patients with cardiac or renal alterations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The control group underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) without prophylactic treatment
Experimental: Prophylaxis Group
The prophylaxis group received 100 mg of rectal indomethacin 30 minutes before the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure, combined with intravenous Hartmann's solution administered at 3 mL/kg/hr during the procedure, plus a 20 mL/kg bolus given post-procedure, followed by continuous hydration at 3 mL/kg/hr for 8 hours
Drug: Rectal Indometacin
The gold standard for treating diseases affecting the biliopancreatic ducts, choledocholithiasis being the most common indication, for which sphincterotomy is the most frequently performed procedure.
Other Names:
  • ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-ERCP pancreatitis
Time Frame: From the end of the ERCP procedure through 24 hours
Pancreas inflammation after the ERCP procedure
From the end of the ERCP procedure through 24 hours
Post-ERCP pancreatitis
Time Frame: Ocurring in the first 24 hours posterior to the ERCP
Pancreas inflammation due to the ERCP procedure
Ocurring in the first 24 hours posterior to the ERCP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-ERCP Pancreatic enzyme elevation
Time Frame: Ocurring in the first 24 hours posterior to the ERCP
Elevation of the amylase and/or lipase after the ERCP procedure
Ocurring in the first 24 hours posterior to the ERCP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo

Investigators

  • Study Chair: Rubén Cuevas-Martínez, MD, MSc, Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Actual)

December 27, 2024

Study Completion (Actual)

January 17, 2025

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0344/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Out of respect for Mexican legislation regarding the confidentiality of information of private individuals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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