Validation of Clinical Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Duration of ERCP treatment
研究概览
简要总结
Validation of clinical use of additioned endoscopy in Endoscopic Retrograde Cholangiopancreatography(ERCP) treatment.
详细描述
Investigators recently developed a device named additioned Endoscopy. The purpose of current clinical trial is to evaluate the use of additioned endoscopy in ERCP treatment, specifically in shortening the duration of ERCP operation and lowering incidence of complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People who are indicated to ERCP treatment.
排除标准
- •People who are not suitable for ERCP treatment.
研究组 & 干预措施
ERCP with additioned endoscopy
This arm will include participants undergoing ERCP with assistance of additioned endoscopy.
干预措施: Additioned Endoscopy (Device)
ERCP without additioned endoscopy
This arm will include participants undergoing ERCP without assistance of additioned endoscopy as negative controls.
结局指标
主要结局
Duration of ERCP treatment
时间窗: Duration of operation in each patient, ie. from beginning to the end of ERCP operation in each patient
To test if additioned endoscopy will have impact on duration of ERCP treatment
次要结局
- complications of ERCP treatment(up to 1 month after ERCP completion)
研究者
Xiangyu Kong
Doctor of gastroenterology department
Changhai Hospital