Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis

Официальное название

Comparison Between Local Cryoprevention Associated With NSAIDs Versus NSAIDs Alone for Reducing the Incidence of Post-ERCP Pancreatitis: a Randomized Clinical Trial

Обзор

The standard prophylaxis for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is performed with rectal non-steroidal anti-inflammatory drugs (NSAIDs). A recent Japanese study demonstrated the efficacy of irrigating the periampullary region with ice water, however without the concomitant use of NSAIDs. The proposed study is a randomized, single-center, single-blind clinical trial that aims to compare the efficacy of rectal NSAIDs alone versus NSAIDs associated with ice water in the prevention of PEP.

Подробное описание

This study aims to evaluate the efficacy of instilling ice-cold distilled water (4ºC to 5ºC) into the second duodenal portion as an adjunct to the standard practice of using NSAIDs, comparing it with a group using NSAIDs only to reduce the incidence of PEP. This is a randomized, sequential, blinded, 1:1 paired clinical trial conducted at a single tertiary center. An initial sample of 530 participants was calculated; considering a 10% drop-out, the final calculation was 583 people. All patients will undergo ERCP under sedation or general anesthesia and will be hydrated intravenously with lactated Ringer's. Rectal administration of NSAIDs (indomethacin 100mg) will be performed for all patients without contraindications. In the intervention group, immediately after the end of the therapeutic ERCP, 250 ml of ice-cold distilled water (4º to 5ºC) will be injected towards the papillary region. The control group will undergo standard ERCP and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.

Вмешательства

• Процедура NSAID alone
  Standard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.
• Процедура Cryoprevention associated with NSAID
  Standard ERCP, hydration with lactated Ringer's, rectal administration of NSAIDs (indomethacin 100mg), and irrigation of the duodenal papilla with 250 ml of ice-cold distilled water (4º to 5ºC).

Первичные конечные точки

• Incidence of Post-ERCP Pancreatitis (PEP). [Срок оценки: Immediately after the procedure until 03 days after the procedure]

Вторичные конечные точки (5)

• PEP Severity [Срок оценки: Day 1 (24 hours post-procedure) and 7 days post-procedure]
• Cholangitis [Срок оценки: Day 1 (24 hours post-procedure) and 7 days post-procedure]
• Bleeding [Срок оценки: Day 1 (24 hours post-procedure) and 7 days post-procedure]
• Perforation [Срок оценки: Day 1 (24 hours post-procedure) and Day 7 (7 days post-procedure)]
• Mortality [Срок оценки: Up to 90 days post-procedure]

Критерии участия

Критерии включения

• Patients aged 18 years or older
• Clinical indication for ERCP
• Presence of native major duodenal papilla without previous manipulation
• Ability of the patient or companion to provide informed consent.

Критерии исключения

• Contraindication to ERCP (e.g., severe hemodynamic instability, visceral perforation)
• Ongoing acute pancreatitis (except mild biliary where ERCP is therapeutic and pain has already resolved)
• Inaccessibility of the duodenal papilla (e.g., Gastrectomies with Billroth II and Roux-en-Y reconstruction, or gastroduodenal obstructions)
• Pregnant women
• Refusal to participate in the study or inability to sign the ICF
• Contraindication to NSAID use.

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

Бразилия · 1 центр

• Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina d — São Paulo

Публикации

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• Janssens LP, Yamparala A, Martin J, O'Meara J, Harmsen WS, Sathi T, Lemke E, Abu Dayyeh BK, Bofill-Garcia A, Petersen BT, Storm AC, Topazian M, Vargas EJ, Chandrasekhara V, Law RJ. Incidence of Post-ERCP Pancreatitis in Patients Receiving Rectal Indomethacin vs. Compounded Rectal Diclofenac Prophylaxis. Dig Dis Sci. 2024 Oct;69(10):3970-3978. doi: 10.1007/s10620-024-08604-5. Epub 2024 Aug 31. PMID 39215866
• Azuma S, Kobayashi Y, Harada R, Yane K, Sawada K, Tsujimoto A, Inatomi O, Matsumori T, Yoshimura K, Yazumi S, Kurita A. Local Postprocedural Cryoprevention Significantly Reduces the Incidence of Post-ERCP Pancreatitis: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2025 Jul 10. doi: 10.14309/ajg.0000000000003644. Online ahead of print. PMID 40638082
• Azuma S, Kurita A, Katayama T, Iwano K, Iimori K, Kawai Y, Sawada K, Yazumi S. Cooling the papilla with ice water in preventing post-ERCP pancreatitis (ice water challenge study). Surg Endosc. 2022 Aug;36(8):6002-6006. doi: 10.1007/s00464-021-08924-x. Epub 2022 Jan 3. PMID 34977992
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• ASGE STANDARDS OF PRACTICE COMMITTEE; Buxbaum JL, Freeman M, Amateau SK, Chalhoub JM, Chowdhury A, Coelho-Prabhu N, Das R, Desai M, Elhanafi SE, Forbes N, Fujii-Lau LL, Kohli DR, Kwon RS, Machicado JD, Marya NB, Pawa S, Ruan WH, Sadik J, Sheth SG, Thiruvengadam NR, Thosani NC, Zhou S, Qumseya BJ; (ASGE Standards of Practice Committee Chair). American Society for Gastrointestinal Endoscopy guidelin PMID 36517309
• 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

Идентификаторы

NCT: NCT07738094 · 97150326.3.0000.0068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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