Evaluation of the Cannulation Time During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire. Multicentre Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Time of cannulation
研究概览
简要总结
The aim of this study is to compare the cannulation time during primary wire guided ERCP (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.
详细描述
In primary Endoscopic Retrograde Cholangio-Pancreatography (ERCP) cannulation is wire guided. Up to now there is no doubt about the efficacy of such a procedure. The use of long wire requires the help of another person behind primary operator. The use of short wire rapid exchange allows the primary operator to perform all the steps by himself. Time of cannulation is known to be directly associated to post ERCP pancreatitis.
Aim of the study is to assess which length of guide wire allows the shorter cannulation time during primary ERCP. Post ERCP pancreatitis onset will be assessed for all patients
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indication to primary ERCP
- •ASA (American Society of Anesthesiologists) 1, 2, 3
排除标准
- •pancreas neoplasia
- •pancreatitis
- •ampulloma
- •duodenum stenosis
- •under mucous membrane haematoma
研究组 & 干预措施
Short guide wire rapid exchange
Use of short guide wire rapid exchange to guide the cannulation during primary ERCP
干预措施: Short guide wire rapid exchange (Device)
Long guide wire
Use of long wire to guide the cannulation during primary ERCP
干预措施: Long guide wire (Device)
结局指标
主要结局
Time of cannulation
时间窗: 8 hours from intervention
Time (in seconds) required to perform a complete and successful deep cannulation of the "biliary papilla" and the biliary tree assessed by timing it and reporting it in the prefashioned database
次要结局
- Incidence of post ERCP pancreatitis(8 hours post ERCP)