NCT06612931已完成不适用
Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures: a Multicenter, Randomized, Crossover Trial
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2023年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- The diagnostic accuracy
研究概览
简要总结
In this randomized crossover trial involving patients with indeterminate biliary strictures, we aimed to compare the diagnostic performance of the dual-lumen catheter-guided miniforceps biopsy (CMB) device with that of brush cytology under aspiration (BCA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-88 years old.
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
- •Biliary obstructive symptoms,or indeterminate biliary stricture suspected to be intrinsic based on prior imaging.
排除标准
- •Any contraindications to ERCP.
- •Severe cardiopulmonary disease or coagulopathy.
- •Biliary strictures caused by extrinsic compression.
- •Unwillingness or inability to provide consent.
- •Pregnant or breastfeeding women.
结局指标
主要结局
The diagnostic accuracy
时间窗: 6 months
The accuracy of dual-lumen catheter-guided miniforceps biopsy (CMB) and brush cytology with vacuum aspiration (BCA) in the diagnosis of biliary strictures.
次要结局
- the diagnostic sensitivity(6 months)
- The diagnostic specificity(6 months)
- Severe adverse events rates(6 months)
研究者
Baiwen Li
Director of the Gastrointestinal Endoscopy Center
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (2)
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