Prophylaxis Against Post-Endoscopic Retrograde Cholangio-Pancreatography Pancreatitis.

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07599605

Acronym

Post-ERCP

Enrollment

Registered

2026-05-20

Start date

2024-03-04

Completion date

2025-01-17

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ERCP, Pancreatitis

Keywords

ERCP, Rectal indomethacin, Hydration, Post-ERCP pancreatitis, Prophylaxis, Amylase, Lipase, Biliopancreatic complications

Brief summary

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.

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.

Interventions

DRUGRectal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

To determine if a prophylactic dose of rectal indomethacin plus an aggressive hydration scheme reduces the incidence of post-ERCP pancreatitis, a randomized controlled study (RCT) was designed in the surgery department of a secondary-care teaching hospital.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Patients with cardiac or renal alterations

Design outcomes

Primary

Measure	Time frame	Description
Post-ERCP pancreatitis	From the end of the ERCP procedure through 24 hours	Pancreas inflammation after the ERCP procedure

Secondary

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

Countries

Mexico

Contacts

STUDY_CHAIRRubén Cuevas-Martínez, MD, MSc

Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026