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Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis
Sponsor: Johns Hopkins University
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).
Official title: A Randomized Trial Comparing Rectal Indomethacin Alone Versus a Combination of Rectal Indomethacin and Oral Tacrolimus for Post-ERCP Pancreatitis Prophylaxis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4874
Start Date
2023-01-18
Completion Date
2026-12
Last Updated
2025-12-09
Healthy Volunteers
No
Conditions
Interventions
Tacrolimus capsule
Tacrolimus 5 mg PO, 1-2 hours prior to endoscopy
Placebo
Placebo PO, 1-2 hours prior to endoscopy.
Rectal 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