Common painkiller may prevent pancreatitis after bile duct procedure
NCT ID NCT07661498
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests whether a single dose of rectal indomethacin, a common anti-inflammatory drug, can prevent pancreatitis in patients undergoing a bile duct procedure (ERCP) who have had a prior sphincterotomy. About 860 adults will be randomly assigned to receive the drug or no drug before the procedure. The study aims to see if this simple preventive measure reduces the risk of post-procedure pancreatitis in this specific group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- indomethacin (rectal suppository)
- What this could lead to
- If effective, this could provide a simple, low-cost way to prevent pancreatitis after ERCP in patients who have had a prior sphincterotomy.
- What could go wrong
- This is a phase 4 trial in a specific, lower-risk population, so results may not apply broadly. The drug may not show significant benefit over no treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 860 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female ≥ 18 years of age at the time of ERCP. 2. Scheduled to undergo routine biliary ERCP with documentation of a prior biliary sphincterotomy. 3. Ability to receive rectal medication. 4. Ability and willingness to comply with all study procedures and follow-up requirements. 5. 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: 1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 2. Known hypersensitivity or contraindication to indomethacin, other nonsteroidal anti-inflammatory drugs, or suppository components. 3. Active gastrointestinal bleeding, history of NSAID-induced gastrointestinal ulceration, or other conditions that contraindicate NSAID use. 4. 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). 5. Current use of other NSAIDs that cannot be safely discontinued per the investigator's judgment. 6. Known chronic pancreatitis 7. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of California, San Francisco
San Francisco, California, 94158, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Blood cell ratios may flag dangerous pancreatitis early