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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 30 days of ERCP |
| Incidence of ERCP-Related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vu Dinh, MD, PhD | Contact | 7142249012 | Vu.Dinh@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Larsen, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40911498 | Background | 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. | |
| 31863440 | Background |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007213 | Indomethacin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
Incidence of ERCP-related complications, including bleeding, infection, and perforation, occurring after the ERCP procedure. |
| 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. | 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. | Within 30 of ERCP Procedure |
| 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. |
| 30979521 | 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. |
| 22494121 | 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. |