Indomethacin for Biliary ERCP Patients

NCT07661498 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-44446
• Study Type: interventional
• Target: 860
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

ERCP; pancreatitis; post-ERCP pancreatitis; PEP; pancreatitis acute biliary; post-ERCP adverse events

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-ERCP Pancreatitis

  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 placebo.

  Within 30 days following ERCP Procedure

Secondary Outcomes (4)

• Severity of Post-ERCP Pancreatitis

  Within 30 days of ERCP

• Incidence of ERCP-Related Adverse Events

  Within 30 days of ERCP Procedure

• Incidence of Indomethacin-Related Adverse Events

  Within 30 days of ERCP Procedure

• Hospital Admission Following ERCP

  Within 30 of ERCP Procedure

Study Arms (2)

Indomethacin

EXPERIMENTAL

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.

Drug: indomethacin

Digital Rectal Exam

NO INTERVENTION

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.

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.

Also known as: rectal indomethacin

Indomethacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (4)

• Sawaf B, Najah Q, Almoshantaf MB, Alom M, Hallak YO, Albuni MK, Elhadi M, Alastal Y. Rectal Indomethacin in Preventing Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: An Updated Meta-Analysis with Trial Sequential Analysis. Dig Dis. 2025;43(6):706-717. doi: 10.1159/000548343. Epub 2025 Sep 5.

  PMID: 40911498 BACKGROUND

• Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.

  PMID: 31863440 BACKGROUND

• ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.

  PMID: 30979521 BACKGROUND

• Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.

  PMID: 22494121 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael Larsen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vu Dinh, MD, PhD

CONTACT

7142249012; Vu.Dinh@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)