The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases: a Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Diagnotic yield
研究概览
简要总结
Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.
详细描述
Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety. This is a 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 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.
研究组 & 干预措施
the freezing time of 3s
Transbronchial cryobiopsy in the freezing time of 3s
干预措施: Transbronchial Cryobiopsy (Procedure)
the freezing time of 4s
Transbronchial cryobiopsy in the freezing time of 4s
干预措施: Transbronchial Cryobiopsy (Procedure)
the freezing time of 5s
Transbronchial cryobiopsy in the freezing time of 5s
干预措施: Transbronchial Cryobiopsy (Procedure)
the freezing time of 6s
Transbronchial cryobiopsy in the freezing time of 6s
干预措施: Transbronchial Cryobiopsy (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(one week)
研究者
ShiYue Li
Director of the Respiratory department
Guangzhou Institute of Respiratory Disease