NCT02380326Unknown不适用
Innovation in Endobronchial Sampling : Integration of Virtual Bronchoscopic Navigation in the Current Diagnostic Algorithm and the Use of Micro-CT for Tissue Analysis
适应症
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
Evaluating an integrated diagnostic work-up of virtual navigation bronchoscopy (VNB), confocal laser endomicroscopy and micro computerized tomography (micro-CT) in the diagnostic path of pulmonary lesions in the non-oncological patient.
详细描述
The region(s) of interest that has/have to be sampled, will be selected upfront. Guided by the endobronchial pathway that is created by virtual bronchoscopy, the flexible bronchoscope will be navigated to the regions of interest and an optical biopsy of the region will be obtained using pCLE. One biopsy sample will be processed in the endoscopy suite to be able to prepare it for micro-CT analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Presence of diffuse pulmonary disease necessitating bronchoscopic evaluation.
- •Informed consent available
- •Age > 18
- •FVC > 50%pred
- •DLCO > 35%pred
- •PaO2 > 55 mmHg, pCO2 < 45 mmHg (ambient air)
- •No exclusion criteria
排除标准
- •Age > 75
- •Systolic arterial pressure in the pulmonary artery : PAPS >40mmHg
- •Platelet count <100000/µl
- •INR > 1.4
- •Diffuse bullous lung disease
- •Active anti-platelet or anticoagulant treatment
- •Active heart failure or unstable coronary heart disease
结局指标
主要结局
Diagnostic yield
时间窗: postprocedural
次要结局
未报告次要终点
研究者
研究点 (1)
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