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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Post-ERCP Acute Pancreatitis

In brief

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).

Key facts

Study ID

NCT05252754

Run by

Johns Hopkins University

People needed

4874

Starts

2023-01-18

Expected to finish

2026-12-01

Last updated by the study team

2025-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient who is undergoing endoscopic retrograde cholangiopancreatography (ERCP) at any of the participating centers, is at least 18 years old and provides informed consent can be included in the study.

You may not qualify if…

• 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.
• Acute pancreatitis within 30 days of ERCP.
• Pancreatic head malignancy.
• Sphincter of Oddi dysfunction (Type 3).

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Asian Institute of Gastroenterology — Hyderabad, Andhra Pradesh, India (enrolling)
• Apollo Multispecialty Hospitals, — Kolkata, West Bengal, India
• Post Graduate Institute of Medical Education and Research — Chandigarh, India
• Singapore General Hospital — Singapore, Singapore

Full record on ClinicalTrials.gov

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