Efficacy of Single-operator Cholangioscopy to Screen for Neoplastic Bile Duct Lesions in Patients With Bile Duct Stones
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- detection rate
研究概览
简要总结
This is the prospective observational study to explore whether the SpyGlass DS II system could be used to screen early-stage neoplastic bile duct lesions in selected patients.
详细描述
It is difficult to diagnose neoplastic bile duct lesions (including cholangiocarcinomas) via direct endoscopic evaluation of the bile duct. Most evaluations of biliary lesions have used indirect imaging modalities such as CT, MRI, or ERCP. However, CT and MRI do not yield tissue diagnoses, unlike ERCP, although the diagnostic accuracy for the latter remains unsatisfactory. Recently, remarkable advances in cholangioscopic systems have been made. Of the currently available cholangioscopic systems, the SpyGlass (Boston Scientific Co, Natick, Mass, USA) is a disposable cholangioscope permitting 4-way deflected steering by a single operator. We aimed to evaluate the efficacy of single-operator cholangioscopy (SpyGlass DS II system) to screen for neoplastic bile duct lesions in patients with bile duct stones, which is one of the risk factor of cholangiocarcinoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged > 18 years
- •Patients with risk factors for CCA (viral hepatitis, parasitic infection, choledochal cyst, primary sclerosing cholangitis, biliary stones, and toxins)
- •Patients who undergo ERCP for confirmation of CBD clearance
- •Dilated common bile duct (> 10 mm)
- •Previous sphincteroplasty, such as major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation
排除标准
- •Presence of biliary tract cancer
- •Presence of distal CBD stricture
- •Bleeding tendency (INR>1.5 or platelets <50000 mm3)
- •Contraindications of ERCP
结局指标
主要结局
detection rate
时间窗: Until the end of the single-operator cholangioscopy session (up to 20 minutes)
detection rate of intraductal neoplastic lesions in patients with bile duct stones who underwent single-operator cholangioscopy
次要结局
- Adverse events(From the start of endoscopy to the end of the study observation period (at least 12 months))
- Technical success of cholangioscopy(Up to 15 minutes from the time the endoscope passes through the oral cavity)
- Technical success of cholangioscopy-guided biopsy(Until the end of the single-operator cholangioscopy session (up to 20 minutes))
- Number needed to screen(From the start of endoscopy to the end of the study observation period (at least 12 months))
研究者
Jong Ho Moon
MD, PhD, FASGE, FJGES
Soonchunhyang University Hospital