Low-Dose Versus Standard-Dose Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicentre, Non-Inferiority, Double-Blind, Randomised, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,366
- 试验地点
- 12
- 主要终点
- The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Patients planned to undergo Endoscopic Retrograde Cholangiopancreatography
排除标准
- •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
研究组 & 干预措施
low dose indomethacin
patients randomized to this intervention receive 50mg indomethacin
干预措施: low dose indomethacin (Drug)
standard dose indomethacin
patients randomized to this intervention receive 100mg indomethacin
干预措施: standard dose indomethacin (Drug)
结局指标
主要结局
The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis
时间窗: Within 48 hours after ERCP
次要结局
- The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis(Within one month of ERCP)
- Rate of Overall ERCP-related complications(Within one month of ERCP)
- Rate of ERCP-related perforation(Within one month of ERCP)
- Rate of ERCP-related infection(Within one month of ERCP)
- Rate of ERCP-related bleeding(Within one month of ERCP)
- Rate of NSAIDs-related complications(Within one month of ERCP)