Risk Factors Related to Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis in High-risk Patients Who Underwent ERCP and Received Prophylactic Rectal Indomethacin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 790
- 试验地点
- 3
- 主要终点
- Overall PEP rate
研究概览
简要总结
Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis (PEP)remains the most frequent adverse event of ERCP. Rectal indomethacin, as one kind of classic NSAIDs, has been proved to be effective in reducing the incidence of PEP. It has been widely used to prevent PEP in patients, especially those with potentially high risks of PEP. However, rectal indomethacin can not completely eradicate the occurrence of PEP. The rate of PEP in patients receiving indomethacin ranges from 3.2% to 9.2%. The risk factors of PEP in patients receiving rectal indomethacin remains unclear. The aim of the study was to identify potential risk factors in high-risk patients whose received administration of prophylactic rectal indomethacin after ERCP.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing diagnostic or interventional ERCP
- •Receiving administration of rectal indomethacin(100mg) after ERCP
- •High risk patients determined at the discretions of endoscopists
排除标准
- •Dose other than 100mg
- •Acute pancreatitis within 3 days before ERCP
- •Average risk patients at the discretions of endoscopists
- •Using NSAIDs within 7 days before ERCP
- •Without cannulation attempts
- •Administration of rectal indomethacin before or during ERCP
结局指标
主要结局
Overall PEP rate
时间窗: 1 year
PEP was defined if patients experienced abdominal pain for more than 24h after procedure, accompanying with amylase or lipase ≥ 3 times equal to the upper limit of normal value.
次要结局
- The rate of moderate-severe pancreatitis(1 year)
- Overall ERCP-related complication rate(1 year)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China