Pancreatic Sphincterotomy Versus Double Wire Technique in Difficult Cannulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,190
- 试验地点
- 1
- 主要终点
- Post ERCP pancreatitis defined by ESGE guidelines published 2014
研究概览
简要总结
The purpose of the study is to compare two different techniques (pancreatic sphincterotomy (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and the success of cannulation in difficult cannulation. For the study, the difficult cannulation is de-fined as situation when the common bile duct has not been cannulated in five minutes, after five attempts or after two pancreatic guide wire passages or when any of those limits is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The primary end-point is the risk 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
- Treatment
- 盲法
- None
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
- •Naive papilla, ERCP indication common bile duct cannulation
排除标准
- •No consent to the study
- •Ongoing pancreatitis
研究组 & 干预措施
Pancreatic sphincterotomy
Pancreatic sphincterotomy technique used in difficult biliary cannulation
干预措施: Biliary cannulation (Procedure)
Double guide wire
Double guide wire technique used in difficult biliary cannulation
干预措施: Biliary cannulation (Procedure)
结局指标
主要结局
Post ERCP pancreatitis defined by ESGE guidelines published 2014
时间窗: 48 hours
Acute pancreatitis within 48 hours post ERCP. Post-ERCP pancreatitis (PEP) is defined as the presence of abdominal pain attributable to acute pancreatitis, together with a need for an unplanned hospitalization or an extension of a planned hospitalization by at least 2 days, and a serum /plasma amylase at least 3 times above the upper limit of normal at 24 hours after the procedure.
次要结局
- Biliary cannulation success within 15 minutes after randomization(15 minutes)
- Biliary cannulation success, total number(2 hours)
研究者
Leena Kylanpaa
M.D, Ph.D
Helsinki University Central Hospital