Single-operator Wire-guided ERCP Cannulation Technique: a Single-center Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 465
- 试验地点
- 1
- 主要终点
- Cannulation success rate
研究概览
简要总结
The single-operator wire-guided cannulation technique doesn't require an experienced assistant and precise coordination between the assistant and endoscopist.
详细描述
A new single-operator wire-guided cannulation technique was performed on all patients. All procedures were performed by the same experienced endoscopist, but with different assistants in two groups (with an experienced one in Group A, and a new trained one in Group B). The number of attempts at cannulation, cannulation time, success rate, and procedure-related complications were compared between the two groups.
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
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospitalized patients with pancreas and biliary diseases referred to the authors for ERCP
排除标准
- •previous endoscopic sphincterotomy,
- •surgically altered anatomy (e.g. Billroth II gastrectomy) or
- •diagnostic duodenoscopy
研究组 & 干预措施
experienced assistant group
experienced endoscopist with an experienced assistant.
干预措施: Team 1 (Procedure)
new trained assistant group
same experienced endoscopist with a new trained assistant
干预措施: Team 2 (Procedure)
结局指标
主要结局
Cannulation success rate
时间窗: two years
次要结局
- Incidences of post-ERCP pancreatitis(two years)
- Incidences of bleeding(two years)
- Incidences of perforation(two years)
- Incidences of infection(two years)
- Number of attempts at cannulation(two years)
- Cannulation time(two years)
研究者
Qi-yong Li
Clinical Professor
Zhejiang University