The Usefulness of Disposable Digital Single-operator Cholangioscopy and Intraductal Ultrasound in the Assessment of Nonicteric Biliary Strictures: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- diagnostic accuracy of SOC
研究概览
简要总结
This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture.
详细描述
Although early and accurate diagnosis of cholangiocarcinoma from the biliary stricture is important, accurate differential diagnosis is still difficult even in computed tomography and magnetic resonance imaging. We planned to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of biliary stricture.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 to under 80
- •Presence of nonicteric biliary stricture
- •Previous endoscopic sphincterotomy or papillary balloon dilatation
排除标准
- •Bleeding tendency (INR > 1.5 or platelets < 50000 mm3)
- •Contraindication to ERCP
结局指标
主要结局
diagnostic accuracy of SOC
时间窗: From enrollment through study completion, an average of 1 year
sensitivity, specificity, and accuracy of SOC
次要结局
- Diagnostic accuracy of IDUS(From enrollment through study completion, an average of 1 year)
- Technical success of IDUS(From the time the intraductal probe is inserted into the working channel of the endoscope until it is removed)
- Technical success of SOC(From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed)
- Adverse event(From enrollment through study completion, an average of 1 year)
研究者
Jong Ho Moon
Professor Jong Ho Moon
Soonchunhyang University Hospital