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Use of an Anti-Inflammatory Drug (Indomethacin) to Prevent Pancreatic Inflammation after an Endoscopic Procedure (ERCP)

Indomethacin in the Prevention of Post-ERCP Pancreatitis in a Low Risk Population: Placebo-Controlled Study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-9q5kr7m
Enrollment
852
Registered
2026-04-14
Start date
2025-12-09
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Unspecified Procedural Complication Acute Pancreatitis

Interventions

This is a randomized clinical trial with three arms, double blind. The estimated sample for each group is 284 patients who meet the eligibility criteria will be probabilistically allocated to one or a

Sponsors

Julio Carlos Pereira Lima
Lead Sponsor
Universidade Federal de Ciências da Saúde de Porto Alegre
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age, who are referred to the Neuroradiology Service of Hospital São José do Complexo Santa Casa de Misericórdia de Porto Alegre to undergo ERCP, who, after due explanations about the study, accept to participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Allergy to indomethacin, previous digestive bleeding or history of peptic ulcer disease, chronic renal failure, bile duct prosthesis or previous papillotomy.

Design outcomes

Primary

MeasureTime frame
Verify the incidence and demographics of cases of post-ERCP (Endoscopic retrograde cholangiopancreatography) acute pancreatitis in our population of patients.

Secondary

MeasureTime frame
A reduction in the rates of post-ERCP (Endoscopic retrograde cholangiopancreatography) acute pancreatitis in our patient population is expected through the application of indomethacin through two routes, based on the finding of a 4% variation from the placebo group to the intervention groups.

Countries

BR

Contacts

Public ContactJulio Pereira Lima

Universidade Federal de Ciências da Saúde de Porto Alegre

jpereiralima@terra.com.br+555133038700

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026