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Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis
RecruitingPhase 3
A Randomized Trial Comparing Rectal Indomethacin Alone Versus a Combination of Rectal Indomethacin and Oral Tacrolimus for Post-ERCP Pancreatitis Prophylaxis
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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. 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. * Acute pancreatitis within 30 days of ERCP. * Pancreatic head malignancy. * Sphincter of Oddi dysfunction (Type 3).
About the study
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).
What is being tested
- Tacrolimus capsule (drug)
- Placebo (drug)
- Rectal Indomethacin (drug)
Sponsor: Johns Hopkins University · Participants: 4,874 · Started: Jan 18, 2023
Contact the study team
- Venkata S. Akshintala, M.D. · Phone: +1 (410) 614-6708
Official record on ClinicalTrials.gov — NCT05252754
Locations in the U.S.
| Maryland | Johns Hopkins Hospital, Baltimore |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.