[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07661498":3,"trial-entities:NCT07661498":126,"trial-summary:NCT07661498":130},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":48,"secondary_outcomes":53,"sex":69,"minimum_age":70,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":75,"locations":78,"central_contacts":105,"overall_officials":108,"references":111,"see_also_links":125},"NCT07661498","25-44446","Indomethacin for Biliary ERCP Patients","Indomethacin vs. no Indomethacin for Patients Undergoing Biliary ERCP With Prior Biliary Sphincterotomy","NOT_YET_RECRUITING","2031-07","2026-06","2026-06-22","2026-07","University of California, San Francisco","OTHER",false,"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.\n\nEligible 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.",null,[19,20,21,22,23,24],"Pancreatitis Biliary","Pancreatitis Acute Biliary","Pancreatitis","Post-ERCP Pancreatitis","Post-ERCP Acute Pancreatitis","Post-ERCP Adverse Events",[26,27,28,29,30,31],"ERCP","pancreatitis","post-ERCP pancreatitis","PEP","pancreatitis acute biliary","post-ERCP adverse events","INTERVENTIONAL","PREVENTION",[35],"PHASE4",{"count":37,"type":38},860,"ESTIMATED",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":46},"DRUG","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.",[45],"Indomethacin",[47],"rectal indomethacin",[49],{"measure":50,"description":51,"timeFrame":52},"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",[54,58,62,65],{"measure":55,"description":56,"timeFrame":57},"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",{"measure":59,"description":60,"timeFrame":61},"Incidence of ERCP-Related Adverse Events","Incidence of ERCP-related complications, including bleeding, infection, and perforation, occurring after the ERCP procedure.","Within 30 days of ERCP Procedure",{"measure":63,"description":64,"timeFrame":61},"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.",{"measure":66,"description":67,"timeFrame":68},"Hospital Admission Following ERCP","Proportion of participants requiring hospitalization or unplanned admission following ERCP due to post-procedure complications.","Within 30 of ERCP Procedure","ALL","18 Years",{"inclusion":72,"exclusion":73,"raw_text":74},[],[],"Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age at the time of ERCP.\n2. Scheduled to undergo routine biliary ERCP with documentation of a prior biliary sphincterotomy.\n3. Ability to receive rectal medication.\n4. Ability and willingness to comply with all study procedures and follow-up requirements.\n5. 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.\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n2. Known hypersensitivity or contraindication to indomethacin, other nonsteroidal anti-inflammatory drugs, or suppository components.\n3. Active gastrointestinal bleeding, history of NSAID-induced gastrointestinal ulceration, or other conditions that contraindicate NSAID use.\n4. Significant renal impairment (e.g., baseline serum creatinine above institutional upper limit of normal or estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²).\n5. Current use of other NSAIDs that cannot be safely discontinued per the investigator's judgment.\n6. Known chronic pancreatitis\n7. 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.",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":13,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":102},"San Francisco","California","94158","United States",[85,90,93,95,98,100],{"name":86,"role":87,"phone":88,"email":89},"Michael C Larsen, MD","CONTACT","415-502-4444","Michael.Larsen@ucsf.edu",{"name":91,"role":87,"email":92},"Vu Dinh, MD, PhD","Vu.Dinh@ucsf.edu",{"name":86,"role":94},"PRINCIPAL_INVESTIGATOR",{"name":96,"role":97},"Sun-Chuan Dai, MD","SUB_INVESTIGATOR",{"name":99,"role":97},"Patrick Avila, MD, MPH",{"name":101,"role":97},"Abdul Kouanda, MD",{"lat":103,"lon":104},37.77493,-122.41942,[106],{"name":91,"role":87,"phone":107,"email":92},"7142249012",[109],{"name":110,"affiliation":13,"role":94},"Michael Larsen, MD",[112,116,119,122],{"pmid":113,"type":114,"citation":115},"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\u002F000548343. Epub 2025 Sep 5.",{"pmid":117,"type":114,"citation":118},"31863440","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\u002Fa-1075-4080. Epub 2019 Dec 20.",{"pmid":120,"type":114,"citation":121},"30979521","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\u002Fj.gie.2018.10.001. Epub 2019 Apr 9.",{"pmid":123,"type":114,"citation":124},"22494121","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\u002FNEJMoa1111103.",[],{"nct_id":4,"conditions":127,"biomarkers":129},[21,128],"Post-ERCP acute pancreatitis",[],{"nct_id":4,"found":131,"summary":132,"prompt_version":142},true,{"design":133,"status":134,"heading":135,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This is a randomized study, meaning participants are assigned by chance to receive the indomethacin. The study plans to enroll 860 participants.","completed","Indomethacin for Preventing Pancreatitis After ERCP","This study is looking at whether a medication called indomethacin can help prevent pancreatitis (inflammation of the pancreas) after a procedure called ERCP (endoscopic retrograde cholangiopancreatography). You might be eligible if you are 18 or older, are scheduled for a routine biliary ERCP, and have had a previous biliary sphincterotomy (a cut in the bile duct). Participants will receive a single rectal suppository of indomethacin 100 mg right before their ERCP. The main goal is to see how many people develop pancreatitis within 30 days after the ERCP. This trial aims to clarify if indomethacin helps in this specific group of patients.","Researchers will check for pancreatitis within 30 days after your ERCP procedure.",102,"You would receive a single rectal suppository of indomethacin immediately before your ERCP procedure.","Not stated in the trial record.",[42],"v2"]