NCT07040241尚未招募不适用
Diagnostic Yield and Safety of Probe-based COnfocaL LAser Endomicroscopy and Ultrasound-guided Pleural BiOpsy in Diagnosing Patients With Unknown pleuRAl Effusion: a Protocol of a Multicenter, Randomized cONtrolled Trial (COLLABORATION-Ⅱ）
China-Japan Friendship Hospital0 个研究点目标入组 260 人开始时间: 2025年7月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 主要终点
- Diagnostic yield
研究概览
简要总结
This study aimed to evaluate the diagnostic yield and safety of confocal laser endomicroscopy and ultrasound-guided pleural biopsy in diagnosing patients with unknown pleural effusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Adult patients with exudative pleural effusion of unknown origin
- •Patients with negative pleural fluid cytology results
- •Patients diagnosed with a probable malignant pleural effusion but without a definite diagnosis and requiring further pathological evaluation
- •Patients who are fully informed of the purpose and method of the study, agree to participate in the study, and sign an informed consent form
排除标准
- •Inability or refusal to undergo UGBx
- •Patients with any contraindications for pleural biopsy
结局指标
主要结局
Diagnostic yield
时间窗: The day 7 after patients received CLE-assisted ultrasound-guided pleural biopsy.
The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition.
次要结局
未报告次要终点
研究者
Gang Hou
Deputy Director of the Department of Pulmonary and Critical Care Medicine
China-Japan Friendship Hospital
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