Low-Dose vs Standard-Dose Indomethacin for Preventing Post-ERCP Pancreatitis

Официальное название

Low-Dose Versus Standard-Dose Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicentre, Non-Inferiority, Double-Blind, Randomised, Controlled Trial

Обзор

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a widely used procedure for diagnosing and treating pancreatic and biliary diseases. Despite its benefits, ERCP carries a risk of post-procedure pancreatitis (PEP), which occurs in approximately 12.2% of cases and can significantly increase healthcare costs and patient morbidity. Preventing PEP is crucial for improving patient outcomes and reducing the economic burden of ERCP. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, have been shown to be effective in reducing the incidence of PEP when administered rectally before ERCP. The standard dose recommended by guidelines is 100mg, which has been associated with a significant reduction in PEP rates. However, higher doses of NSAIDs can increase the risk of adverse events, including gastrointestinal bleeding and renal impairment. Therefore, there is a need to determine whether a lower dose can provide similar benefits without increasing these risks. This multicenter, non-inferiority, double-blind, randomized controlled trial will be conducted in China. Participants will be adults aged 18 or older scheduled for ERCP. They will be randomly assigned in a 1:1 ratio to either the low-dose (50mg) or standard-dose (100mg) indomethacin group. The intervention will be administered rectally 30 minutes before the ERCP procedure. The study will follow a double-blind design, ensuring that both patients and investigators are unaware of the treatment allocation. The results of this trial could significantly influence clinical practice by providing evidence on the effectiveness of a lower dose of indomethacin in preventing PEP. This could lead to a reduction in the risk of adverse events associated with higher doses and potentially decrease healthcare costs without compromising patient safety. By optimizing the dosing of indomethacin, this study aims to improve the safety and cost-effectiveness of ERCP procedures.

Вмешательства

• Препарат standard dose indomethacin
  Patients randomized to this intervention receive 100mg indomethacin suppositories within 30 min before ERCP.
• Препарат low dose indomethacin
  Patients randomized to this intervention receive 50mg indomethacin suppositories within 30 min before ERCP.

Первичные конечные точки

• The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis [Срок оценки: Within 48 hours after ERCP]

Вторичные конечные точки (6)

• The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis [Срок оценки: Within one month of ERCP]
• Rate of Overall ERCP-related complications [Срок оценки: Within one month of ERCP]
• Rate of ERCP-related perforation [Срок оценки: Within one month of ERCP]
• Rate of ERCP-related infection [Срок оценки: Within one month of ERCP]
• Rate of ERCP-related bleeding [Срок оценки: Within one month of ERCP]
• Rate of NSAIDs-related complications [Срок оценки: Within one month of ERCP]

Критерии участия

Критерии включения

• Adults aged 18 years or older.
• Patients planned to undergo Endoscopic Retrograde Cholangiopancreatography

Критерии исключения

• Standard contraindications to ERCP
• Allergy to Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
• Use of NSAIDs within 7 days prior to ERCP
• Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction \[Cr >1.4mg/dl=120umol/l\]; presence of coagulopathy before the procedure)
• Acute pancreatitis within 3 days before ERCP
• Hemodynamic instability
• Pregnancy or lactation
• Patients who are unwilling or unable to provide informed consent

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

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 12 центров

• Changhai Hospital — Шанхай
• Ruijin Hospital — Шанхай
• Shanghai General Hospital — Шанхай
• Affiliated Hospital of Jiaxing University — Zhejiang
• Dongyang People's Hospital — Zhejiang
• First Affiliated Hospital of Ningbo University — Zhejiang
• Jinhua Central Hospital — Zhejiang
• People's Hospital of Quzhou — Zhejiang
• … и ещё 4 центра

Идентификаторы

NCT: NCT07088757 · INSPIRE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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