Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- A complete common bile duct accessing rate
研究概览
简要总结
A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct stone or neoplasm. This system consists of a camera, light sources, a working channel, and a water injection channel. The endoscope could be inserted into the common bile duct via the working channel of a commercial duodenoscope. This study aims to test the feasibility and safety of this system. The efficacy of stone and neoplasm diagnosis will also be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with complicated bile duct stone (stone size > 1.5 cm or number of stone > 3 )
- •Patients with indeterminate biliary stricture or obstruction
排除标准
- •Pregnant woman;
- •Patients who are not suitable for ERCP (e.g. behavior disorder, major cognitive-perceptual deficit, etc.).
结局指标
主要结局
A complete common bile duct accessing rate
时间窗: 1 day
To test the device's feasibility
Image quality evaluation: the light brightness and the imaging sharpness in Likert scale
时间窗: 1 day
To test the device's feasibility. About Likert scale, it range from 1 to 5 (1 is worse and 5 is better).
次要结局
- Number of complications (ablation, bleeding, perforation in percentage) or system malfunction(1 day)
- In biliary stone arm: The biggest residual stone size (in cm).(1 day)
- In biliary stricture arm: Number of the lesions with or without presenting of the specific features for DDx of the benign or malignant stricture(1 day)
研究者
Chiao-Hsiung Chuang
Associate Professor
National Cheng-Kung University Hospital