Indomethacin for Biliary ERCP Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: indomethacin.
- Кому может быть актуально
- Состояния в реестре: Pancreatitis Biliary, Pancreatitis Acute Biliary, Pancreatitis, Post-ERCP Pancreatitis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Indomethacin vs. no Indomethacin for Patients Undergoing Biliary ERCP With Prior Biliary Sphincterotomy
Обзор
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.
Вмешательства
- Препарат 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.
Первичные конечные точки
- Incidence of Post-ERCP Pancreatitis [Срок оценки: Within 30 days following ERCP Procedure]
Вторичные конечные точки (4)
- Severity of Post-ERCP Pancreatitis [Срок оценки: Within 30 days of ERCP]
- Incidence of ERCP-Related Adverse Events [Срок оценки: Within 30 days of ERCP Procedure]
- Incidence of Indomethacin-Related Adverse Events [Срок оценки: Within 30 days of ERCP Procedure]
- Hospital Admission Following ERCP [Срок оценки: Within 30 of ERCP Procedure]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- University of California, San Francisco — San Francisco
Публикации
- 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
- 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
- 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. 2 PMID 30979521
- 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 panc PMID 22494121
Идентификаторы
NCT: NCT07661498 · 25-44446