Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Michael Larsen, MD (ucsf)
Headshot of Michael Larsen
Michael Larsen

Description

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.

Official Title

Indomethacin vs. no Indomethacin for Patients Undergoing Biliary ERCP With Prior Biliary Sphincterotomy

Keywords

Pancreatitis Biliary, Pancreatitis Acute Biliary, Pancreatitis, Post-ERCP Pancreatitis, Post-ERCP Acute Pancreatitis, Post-ERCP Adverse Events, ERCP, PEP, Indomethacin, Digital Rectal Exam

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Location

  • University of California, San Francisco
    San Francisco California 94158 United States

Lead Scientist at University of California Health

  • Michael Larsen, MD (ucsf)
    Professor, Medicine, School of Medicine. Authored (or co-authored) 12 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07661498
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 860 study participants
Last Updated