RecruitingPhase 3NCT05252754

Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis

A Randomized Trial Comparing Rectal Indomethacin Alone Versus a Combination of Rectal Indomethacin and Oral Tacrolimus for Post-ERCP Pancreatitis Prophylaxis


Sponsor

Johns Hopkins University

Enrollment

4,874 participants

Start Date

Jan 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This research is being done to see if using oral tacrolimus before endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares three approaches to preventing pancreatitis (inflammation of the pancreas) after ERCP — a procedure used to diagnose and treat bile duct problems. Post-ERCP pancreatitis is the most common and serious complication of this procedure. The three approaches being tested are: rectal indomethacin alone, oral tacrolimus alone, or both drugs combined. You may be eligible if: - You are 18 years or older - You are scheduled to undergo an ERCP procedure at a participating center - You are able to consent to participate You may NOT be eligible if: - You are pregnant or breastfeeding - You have chronic calcific pancreatitis - You have had a prior biliary sphincterotomy (unless a pancreatogram is still planned) - You have active pancreatitis within the last 30 days - You have cancer in the head of the pancreas - You have chronic kidney disease with very low kidney function (GFR below 30) - You have a known contraindication to tacrolimus or NSAIDs - You are currently taking tacrolimus or immune modulators - You have Sphincter of Oddi dysfunction Type 3 - You do not have a rectum Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTacrolimus capsule

Tacrolimus 5 mg PO, 1-2 hours prior to endoscopy

DRUGPlacebo

Placebo PO, 1-2 hours prior to endoscopy.

DRUGRectal Indomethacin

100 mg Rectal Indomethacin immediately after ERCP, in high-risk patients.


Locations(5)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, India

Apollo Multispecialty Hospitals,

Kolkata, West Bengal, India

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Singapore General Hospital

Singapore, Singapore

View Full Details on ClinicalTrials.gov

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NCT05252754


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