NCT03704233Unknown不适用
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases: a Prospective, Multicenter, Real World Study
Guangzhou Institute of Respiratory Disease26 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2018年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 26
- 主要终点
- Diagnotic yield
研究概览
简要总结
The Diagnostic yield and Safety of transbronchial cryobiopsy in the diagnosis of diffuse parenchymal lung diseases are investigated in this multicenter, prospective and real world study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data.
- •Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
- •Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed.
排除标准
- •The radiological data indicates non-DPLD
- •The clinical examinations mentioned above are not completed.
- •The patient cannot endure or does not agree the procedure.
结局指标
主要结局
Diagnotic yield
时间窗: two weeks
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy
次要结局
- Complication rate(12 weeks)
研究者
ShiYue Li
Director of Department of Respiratory Medicine
Guangzhou Institute of Respiratory Disease
研究点 (26)
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