NCT02380326
Unknown
Not Applicable
Innovation in Endobronchial Sampling : Integration of Virtual Bronchoscopic Navigation in the Current Diagnostic Algorithm and the Use of Micro-CT for Tissue Analysis
ConditionsDiffuse Interstitial Lung Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diffuse Interstitial Lung Disease
- Sponsor
- KU Leuven
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Diagnostic yield
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Yserbyt Jonas
MD
KU Leuven
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Diagnostic yield
Time Frame: postprocedural
Study Sites (1)
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