Indomethacin for Biliary ERCP Patients (NCT07661498) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Indomethacin for Biliary ERCP Patients
United States860 participantsStarted 2026-07
Plain-language summary
This study is a randomized clinical trial evaluating the efficacy of rectal indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in patients undergoing biliary ERCP who have a history of prior biliary sphincterotomy. While rectal indomethacin has demonstrated benefits in preventing post-ERCP pancreatitis in high-risk patients, its utility in this specific patient subgroup remains unclear. This trial aims to determine whether prophylactic administration of indomethacin offers a measurable benefit over no intervention in this lower-risk population.
Eligible patients will be identified prior to their scheduled biliary ERCP and screened for inclusion criteria. Following informed consent, participants will be randomized to receive either rectal indomethacin or no indomethacin prior to the procedure.
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
. Male or female ≥ 18 years of age at the time of ERCP.
. Scheduled to undergo routine biliary ERCP with documentation of a prior biliary sphincterotomy.
. Ability to receive rectal medication.
. Ability and willingness to comply with all study procedures and follow-up requirements.
. Written informed consent (and assent when applicable) was obtained from the subject or the subject's legal representative, and the subject's ability to comply with the requirements of the study was confirmed.
Exclusion criteria
. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
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
Incidence of Post-ERCP Pancreatitis
Timeframe: Within 30 days following ERCP Procedure
. Known hypersensitivity or contraindication to indomethacin, other nonsteroidal anti-inflammatory drugs, or suppository components.
. Active gastrointestinal bleeding, history of NSAID-induced gastrointestinal ulceration, or other conditions that contraindicate NSAID use.
. Significant renal impairment (e.g., baseline serum creatinine above institutional upper limit of normal or estimated glomerular filtration rate \< 30 mL/min/1.73 m²).
. Current use of other NSAIDs that cannot be safely discontinued per the investigator's judgment.
. Known chronic pancreatitis
. Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.