NCT03958162Unknown不适用
The Comparison of Uniportal and Tubeless Video Assisted Thoracic Surgery and Transbronchial Lung Cryobiopsy Within the Multidisciplinary Discussion Context in the Diagnosis of Interstitial Lung Disease
Guangzhou Institute of Respiratory Disease0 个研究点目标入组 60 人开始时间: 2019年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Diagnotic yield
研究概览
简要总结
To compariing the uniportal and tubeless video assisted thoracic surgery and trnsbronchial lung cryobiopsy within the multidisciplinary discussion context in the diagnosis of interstitial lung disease，and assess the safety and cost-effectiveness. This is a prospective control trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 yrs ≤ age<75yrs
- •Patients diagnosed as interstitial lung disease with comprehensive clinical data (including history, serological test, spirometry test and high resolution computed tomography)
- •Further pathological data was still required after multidisciplinary discussion.
排除标准
- •Severe pulmonary dysfunction: forced vital capacity (FVC) ≤65% or carbon-monoxide diffusion coefficient (DLco) ≤45% of predicted value
- •Pulmonary hypertension: An estimated systolic pulmonary artery pressure>50mmHg on echocardiography
- •Abnormal coagulation parameters or thrombocytopenia (<50*109/L)
- •Severe comorbidities leading to inoperable condition
- •Patients cannot give consent or refuse biopsy
研究组 & 干预措施
uniportal and tubeless video assisted thoracic surgery
Experimental
lung biospy by the uniportal and tubeless video assisted thoracic surgery
干预措施: lung biopsy (Diagnostic Test)
transbronchial lung cryobiopsy
Experimental
transbronchial lung cryobiopsy
干预措施: lung biopsy (Diagnostic Test)
结局指标
主要结局
Diagnotic yield
时间窗: two weeks
Percentage of definitive diagnosis within the multidisciplinary discussion context by two different biopsy methods
次要结局
未报告次要终点
研究者
ShiYue Li
Director of the Respiratory department
Guangzhou Institute of Respiratory Disease
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