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NCT07661498 · ClinicalTrials.gov registry record · Phase 4
Indomethacin for Biliary ERCP Patients
A Phase 4 study, sponsored by University of California, San Francisco.
- Not yet
- Registry status
- Phase 4
- Development phase
- 860
- Enrollment target
NCT07661498: Clinical Trial Phase 4 study, sponsored by University of California, San Francisco.
NCT07661498 is a Phase 4 study that has not yet begun recruiting, run by University of California, San Francisco. The registered enrollment target is 860 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07661498, a Phase 4 study, has not yet begun recruiting, sponsored by University of California, San Francisco.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 860 participants
- Enrollment target
Study 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.
Primary Outcome
The incidence of post-ERCP pancreatitis (PEP) following biliary ERCP, defined using standard consensus criteria: new or worsened abdominal pain consistent with acute pancreatitis, elevation of serum amylase or lipase to at least three times the upper limit of normal within 24 hours after ERCP, and hospitalization or prolongation of planned admission attributable to pancreatitis. The outcome will be compared between participants receiving prophylactic rectal indomethacin and those receiving place
Interventions
- DRUG indomethacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 860 participants |
| Start Date | 2026-07 |
| Est. Completion | 2031-07 |
| Phase | Phase 4 |
What is known before NCT07661498 opens enrollment
NCT07661498 is an interventional study that assigns participants to a tested intervention. The registered 860 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% higher).
The record links to 0 conditions, and to 1 intervention - of which indomethacin is the first listed.
NCT07661498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07661498 about?
NCT07661498 is a clinical study titled "Indomethacin for Biliary ERCP Patients". 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 demonst...
What is the current status of trial NCT07661498?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 860 participants. The study started on 2026-07. Estimated completion is 2031-07.
What interventions are being tested in trial NCT07661498?
The interventions under investigation include: indomethacin (DRUG).
Who is sponsoring clinical trial NCT07661498?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07661498's enrollment target sits among peer trials
860 88th of 2000 higher than 1,913 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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