Indomethacin for Biliary ERCP Patients

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07661498
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Pancreatitis
  • Pancreatitis Acute Biliary
  • Pancreatitis Biliary
  • Post-ERCP Acute Pancreatitis
  • Post-ERCP Adverse Events
  • Post-ERCP Pancreatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • indomethacin — DRUG
    Indomethacin 100 mg administered as a single rectal suppository immediately prior to biliary ERCP for the prevention of post-ERCP pancreatitis. Participants are randomized to receive the study intervention before the procedure.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
860 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Indomethacin
    Participants randomized to this arm will receive a single 100 mg rectal indomethacin suppository administered immediately prior to biliary ERCP for the prevention of post-ERCP pancreatitis.
  • No Intervention: Digital Rectal Exam
    A routine digital rectal examination performed immediately prior to biliary ERCP without administration of prophylactic rectal indomethacin. This procedure is used as the control intervention to maintain participant blinding.

Primary Outcome Measure

Incidence of Post-ERCP Pancreatitis [ Time Frame: Within 30 days following ERCP Procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158
Michael C Larsen, MD
[email protected]
415-502-4444
Vu Dinh, MD, PhD
[email protected]
Michael C Larsen, MD (PRINCIPAL_INVESTIGATOR)
Sun-Chuan Dai, MD (SUB_INVESTIGATOR)
Patrick Avila, MD, MPH (SUB_INVESTIGATOR)
Abdul Kouanda, MD (SUB_INVESTIGATOR)

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