Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Success of biliary cannulation
研究概览
简要总结
The purpose of this study is to give doctors who perform Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in order to examine the bile duct as quickly and safely as possible.
详细描述
Sometimes, in the course of a regular ERCP procedure, techniques used by the doctor to pass a wire into the bile duct can result in the pancreas duct being entered instead. When this happens, the doctor may either remove the wire (known as "single wire" technique) or leave it in and use a second wire ("double wire") to enter the bile duct. This study will try to determine whether the "double wire" technique or the "single wire" technique removing the wire is the safest and most efficient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients undergoing ERCP with primary intent to cannulate the bile duct
- •Written informed consent
排除标准
- •Age < 18 years
- •Non-naive papilla (previous sphincterotomy)
- •Surgically altered anatomy
- •Known/suspected pancreas divisum
- •Suspected SOD/biliary manometry
- •Prior ERCP/stent within 3 months
- •ERCP performed in the Operating Room or at Duke North
- •Pregnancy/breast-feeding
结局指标
主要结局
Success of biliary cannulation
时间窗: 10 minutes after randomization
The primary outcome is incidence of successful deep biliary cannulation within 10 minutes.
次要结局
- Success of biliary cannulation(2 days after the procedure)
- Time to successful biliary cannulation(2 days after the procedure)
- Post-ERCP pancreatitis(2 days after the procedure)