The Diagnostic Yield and Safety of Transbronchial Cryobiopsy Under The Guidance of The Endobronchial Ultrasound in The Pulmonary Periphral Nodule: A Multicenter Prospective Random Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 24
- 主要终点
- Diagnotic yield
研究概览
简要总结
Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety.
详细描述
Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety. This is a multi-center prospective randomized control trial.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients are admitted as Pulmonary Periphral Nodule, while undefined after thorough history collection, laboratory examination and radiological data.
- •The longest diameter of the Pulmonary Periphral Nodule is less than 30mm in HRCT.
- •The Pulmonary Periphral Nodule can be detected by radial-EBUS
- •Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
- •Routine blood test, ECG examination, coagulation function, chest HRCT have been completed.
排除标准
- •The longest diameter of the Pulmonary Periphral Nodule is more than 30mm.
- •The Pulmonary Periphral lesions cannot be detected by the radial endobronchial ultrasound.
- •The clinical examinations mentioned above are not completed. The patient cannot endure or does not agree the procedure
研究组 & 干预措施
Transbronchial cryobiopsy
Transbronchial cryobiopsy was performed in the patiens of pulmonary peripheral nodule
干预措施: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep) (Procedure)
Transbronchial lung biopsy
Transbronchial lung biopsy was performed in the patiens of pulmonary peripheral nodule
干预措施: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep) (Procedure)
结局指标
主要结局
Diagnotic yield
时间窗: six months
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy
次要结局
- Complication rate(one week)
研究者
ShiYue Li
Guangzhou Institute of Respiratory Disease
Guangzhou Institute of Respiratory Disease