Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing Post-ERCP Pancreatitis in Patients With Difficult Cannulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 664
- 试验地点
- 1
- 主要终点
- Overall PEP
研究概览
简要总结
Rectal indomethacin and pancreatic duct (PD) stenting (PDS) are recommended for the prevention of post-ERCP pancreatitis (PEP). However, the effects of the combination of the two methods on preventing PEP are controversial. We hypothesized that some group of patients with difficult cannulation might benefit from the combination of indomethacin plus PDS (IP) compared with indomethacin alone (IN).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients underwent diagnostic or therapeutic ERCP
- •With native papilla
- •With difficult cannulation (cannulation time >10min or cannulation attempts >5 times or inadvertently PD cannulation ≥1)
- •Receiving post-ERCP rectal indomethacin
排除标准
- •Patients with indications of PD cannulation
- •No attempt of cannulation due to inaccessible papilla
- •Non-difficult cannulation
结局指标
主要结局
Overall PEP
时间窗: 30 days
PEP was diagnosed if there was a worsening or new onset of pain in the upper abdomen, an elevation in serum amylase of at least three times of the upper limit of the normal range 24h after the procedure and requiring at least two nights of hospitalization.
次要结局
- Overall ERCP related complication(30 days)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China