Innovation in Endobronchial Sampling

• Conditions: Diffuse Interstitial Lung Disease
• Interventions: Procedure: Advanced endoscopic imaging modalities

• Registration Number: NCT02380326
• Lead Sponsor: KU Leuven

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.

Study Timeline

• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-05
• Study Start: 2015-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-25
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diffuse intersitial lung disease	Advanced endoscopic imaging modalities	Patients suffering from diffuse intersitial lung disease without a certain diagnosis subjected to advanced endoscopic imaging modalities
Lung transplant recipients	Advanced endoscopic imaging modalities	Lung transplant recipients with diffuse parenchymal abnormalities subjected to advanced endoscopic imaging modalities

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	postprocedural

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium