NCT01771419Unknown不适用
Comparison Of Loop-Tip Wire Vs Tradictional Technique In The Cannulation Of The Common Bile Duct
Hospital San Paolo2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- post ERCP pancreatitis rate
研究概览
简要总结
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complications and post-ERCP (Endoscopic retrograde cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access with cannulotome (CT-25 Cook Medical) with contrast injection even if results are conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop in the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.
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
- •high-risk patients for post-ERCP pancreatitis
排除标准
- •age < 18 years
- •allargy to the contrast medium
- •previous biliary or gastric surgery
- •neoplastic patients
- •previous biliary or pancreatic sphincterotomy
结局指标
主要结局
post ERCP pancreatitis rate
时间窗: up to 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
次要结局
- Number of attempts to obtain the cannulation of CBD and number of participants with adverse events as a measure of safety and tolerability(up to 4 weeks)
研究者
Benedetto Mangiavillano
MD
Hospital San Paolo
研究点 (2)
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