Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis (NCT05252754)
A Randomized Trial Comparing Rectal Indomethacin Alone Versus a Combination of Rectal Indomethacin and Oral Tacrolimus for Post-ERCP Pancreatitis Prophylaxis
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (15 items).
Location: Johns Hopkins Hospital — Baltimore, Maryland
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Unwillingness or inability to consent for the study.
- Pregnancy
- Breastfeeding mother
- Chronic calcific pancreatitis
- ERCP for biliary stent exchange or removal
- ERCP in a patient with prior biliary sphincterotomy, but without anticipated pancreatogram.
- Biliary intervention in a patient with pancreas divisum.
- Standard contraindications to tacrolimus or NSAID use.
- Current tacrolimus or immune modulator use.
- Chronic kidney disease with glomerular filtration rate (GFR) \< 30 or acute kidney injury.
- Absence of rectum.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (5 Sites)
- Johns Hopkins Hospital — Baltimore, Maryland
- Asian Institute of Gastroenterology — Hyderabad, Andhra Pradesh
- Apollo Multispecialty Hospitals, — Kolkata, West Bengal
- Post Graduate Institute of Medical Education and Research — Chandigarh,
- Singapore General Hospital — Singapore,
📞 Contact the Study Coordinator
Phone: (410) 614-6708
Email: vakshin1@jhmi.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Post-ERCP Acute Pancreatitis
- Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis — Calgary, Alberta
Explore by condition: All Post-ERCP Acute Pancreatitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.