Pancreatitis BiliaryPhase 4NCT07661498
Indomethacin for Biliary ERCP Patients
A Phase 4 study testing indomethacin in people with Pancreatitis Biliary and Pancreatitis Acute Biliary, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis Biliary, Pancreatitis Acute Biliary, Pancreatitis
- What is being tested?
- indomethacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Jul 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
Michael C Larsen, MD, 415-502-4444, Michael.Larsen@ucsf.edu
Vu Dinh, MD, PhD, Vu.Dinh@ucsf.edu
About this study
Official title: Indomethacin vs. no Indomethacin for Patients Undergoing Biliary ERCP With Prior Biliary Sphincterotomy
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
- Being tested
- indomethacin
- Keywords
- ERCP, pancreatitis, post-ERCP pancreatitis, PEP, pancreatitis acute biliary, post-ERCP adverse events
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indomethacinDrug
Also called rectal indomethacin
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days following ERCP Procedure
Secondary outcomes (4)
Severity of Post-ERCP Pancreatitis
Severity of post-ERCP pancreatitis classified according to standard consensus criteria as mild, moderate, or severe among participants who develop post-ERCP pancreatitis.
Measured: Within 30 days of ERCP
Incidence of ERCP-Related Adverse Events
Incidence of ERCP-related complications, including bleeding, infection, and perforation, occurring after the ERCP procedure.
Measured: Within 30 days of ERCP Procedure
Incidence of Indomethacin-Related Adverse Events
Incidence of adverse events potentially attributable to indomethacin administration, including gastrointestinal bleeding, renal dysfunction, and allergic or hypersensitivity reactions.
Measured: Within 30 days of ERCP Procedure
Hospital Admission Following ERCP
Proportion of participants requiring hospitalization or unplanned admission following ERCP due to post-procedure complications.
Measured: Within 30 of ERCP Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis BiliaryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Larsen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661498
- Sponsor's protocol ID
- 25-44446
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40911498Dumonceau 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.
PubMed 31863440ASGE 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.
PubMed 30979521Elmunzer 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.
PubMed 22494121
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indomethacin vs. no Indomethacin for Patients Undergoing Biliary ERCP With Prior Biliary Sphincterotomy
- ClinicalTrials.gov ID
- NCT07661498
- Acronym / sponsor ID
- 25-44446
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indomethacin | Experimental | Drug: indomethacinParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indomethacinAlso: rectal indomethacinIndomethacin 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. | Drug | Indomethacin |
Primary outcome
Incidence of Post-ERCP Pancreatitis
Time frame: Within 30 days following ERCP Procedure
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.
4 secondary outcomes
Severity of Post-ERCP Pancreatitis
Time frame: Within 30 days of ERCP
Incidence of ERCP-Related Adverse Events
Time frame: Within 30 days of ERCP Procedure
Incidence of Indomethacin-Related Adverse Events
Time frame: Within 30 days of ERCP Procedure
Hospital Admission Following ERCP
Time frame: Within 30 of ERCP Procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 40911498Sawaf 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.
- Background: PubMed 31863440Dumonceau 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.
- Background: PubMed 30979521ASGE 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.
- Background: PubMed 22494121Elmunzer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Larsen, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing indomethacin in people with Pancreatitis Biliary and Pancreatitis Acute Biliary, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vu Dinh, MD, PhD (7142249012, Vu.Dinh@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-ERCP Pancreatitis (time frame: Within 30 days following ERCP Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07661498, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.