Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis (NCT05252754) | Clinical Trial Compass
RecruitingPhase 3
Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis
United States, India, Singapore4,874 participantsStarted 2023-01-18
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of subjects in each study group with Post ERCP Acute Pancreatitis (PEP)