Sahlgrenska EUS ERCP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some of these shortcomings.
The current prospective study, performed in a tertiary University center, aims to study the feasibility, the accuracy and the clinical value of combinatory ERCP and EUS in unclear biliary lesions.
详细描述
The eligible study participants with unclear biliary lesions referred for an ERCP to the Sahlgrenska Univeristy Hospital endoscopy unit will be subjected to ERCP with/without brush cytology followed by EUS with/without FNA.
The results of ERCP and EUS will be compared to the pathology report of surgical specimens in resected patients or to clinical follow up at 12 months post-EUS in non-resected patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unclear lesions or strictures in the biliary tract referred for endoscopy work up
排除标准
- •Patients unwilling to participate
- •Patients unfit for EUS and ERCP
结局指标
主要结局
Diagnostic accuracy
时间窗: 12 months post-EUS
Overall accuracy of ERCP and EUS
次要结局
- Adverse event rate(30 days post-EUS)
研究者
Per Hedenström
MD PhD
Sahlgrenska University Hospital, Sweden