Innovation in Endobronchial Sampling

Catholic University (KU) of Leuven

Status: Unknown

Conditions: Diffuse Interstitial Lung Disease

Treatments: Procedure: Advanced endoscopic imaging modalities

Study type: Observational

Funder types: Other

Identifiers

NCT02380326

150302V02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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
• BMI >30
• Diffuse bullous lung disease
• Active anti-platelet or anticoagulant treatment
• Active heart failure or unstable coronary heart disease

Trial design

20 participants in 2 patient groups

Lung transplant recipients

Description:

Lung transplant recipients with diffuse parenchymal abnormalities subjected to advanced endoscopic imaging modalities

Treatment:

Procedure: Advanced endoscopic imaging modalities

Diffuse intersitial lung disease

Description:

Patients suffering from diffuse intersitial lung disease without a certain diagnosis subjected to advanced endoscopic imaging modalities

Treatment:

Procedure: Advanced endoscopic imaging modalities