Application of Transparent Cap-assisted Digital Cholangioscopy (SpyGlassTM) for Biliary Stricture
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The clearness of visual field
研究概览
简要总结
The transparent cap-assisted endoscope has the function of fixing field of view and increasing visual space. It has been widely used in gastrointestinal examination and treatment. In this study, the investigators intend to apply transparent cap-assisted choledochoscopy to endoscopic biliary tract exploration and biopsy to investigate whether transparent cap-assisted choledochoscopy can improve operability, visual field clarity, and biopsy accuracy.
详细描述
Recently, endoscopy has become more widely used in clinical practice. A straightforward method of improving mucosal visualization involves attachment of a transparent cap to the end of the endoscope. It has been widely used in gastrointestinal examination and treatment.This is a before-after study. In patients with suspected bile duct stricture, tandem ERCP combined with SpyGlass choledochoscopy procedures were carried out on the same day in random order, first without a transparent cap and then with a cap (without-to-with), or first with a cap and then without a cap (with-to-without). The differences in maneuverability, visual field clarity and biopsy accuracy of choledochoscopy with and without transparent cap were recorded to explore the application prospect of transparent cap assisted choledochoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •The indications for ERCP.
- •Written informed consent
排除标准
- •Underlying bleeding disorder
- •The platelet count less than 50×10^9/L
- •Serious cardio-pulmonary, hepatic or renal disease
- •Intolerance to ERCP
- •Other high-risk conditions or disease (such as massive ascites, etc.)
- •Pregnancy
结局指标
主要结局
The clearness of visual field
时间窗: Immediately
The clearness of visual field was evaluated by the operating physician and was rated as "clear" or "not clear."
Intubation rates of bile duct ends, cystic duct openings, and left and right hepatic duct bifurcations
时间窗: Immediately
Comparison of intubation rates between transparent cap SpyGlass and standard SpyGlass
次要结局
- Biopsy accuracy(1 week)