NCT02111707已完成4 期
Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- Rate of Post-ERCP pancreatitis
研究概览
简要总结
To determine if the timing of administration of indomethacin affects the primary outcome of post-ERCP pancreatitis (PEP). Patients undergoing ERCP will be randomly assigned to receive pre or post-procedure rectal indomethacin to prevent the occurrence of PEP.
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
- None
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
- •All patients referred for ERCP at the University of Alberta
- •Age greater than 18 years
- •Ability to provide written informed consent
排除标准
- •Acute pancreatitis
- •Active peptic ulcer disease
- •Rectal disease
- •Aspirin-induced asthma
- •Nonsteroidal anti-inflammatory drug (NSAIDs) induced hypersensitivity
- •Pregnancy
- •Breast feeding
- •Creatinine clearance < 30 ml/min
研究组 & 干预措施
Rectal Indomethacin pre-ERCP
Active Comparator
Patients will receive rectal indomethacin 100mg 30 minutes before procedure (ERCP).
干预措施: Rectal indomethacin 100mg one time before or after ERCP (Drug)
Rectal Indomethacin post-ERCP
Active Comparator
Patients will receive rectal indomethacin 100mg immediately after procedure (ERCP)
干预措施: Rectal indomethacin 100mg one time before or after ERCP (Drug)
结局指标
主要结局
Rate of Post-ERCP pancreatitis
时间窗: 30 days
次要结局
- Severity of Post-ERCP pancreatitis(30 days)
研究者
研究点 (1)
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