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OpenTrials
Completed

NCT Number: NCT07599605

Prophylaxis Against Post-Endoscopic Retrograde Cholangio-Pancreatography Pancreatitis.

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.

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Key information

Conditions

Pancreatitis Digestive System Diseases ERCP Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"

Chihuahua City, Chihuahua, 31000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with cardiac or renal alterations

Treatment and study plan

Rectal Indometacin

Drug

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

Primary outcomes

  1. Post-ERCP pancreatitis

    Time frame: From the end of the ERCP procedure through 24 hours

    Pancreas inflammation after the ERCP procedure

  2. Post-ERCP pancreatitis

    Time frame: Ocurring in the first 24 hours posterior to the ERCP

    Pancreas inflammation due to the ERCP procedure

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo

Other Gov

Registry information

Official study title

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

Acronym: Post-ERCP

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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