Innovation in Endobronchial Sampling

Innovation in Endobronchial Sampling : Integration of Virtual Bronchoscopic Navigation in the Current Diagnostic Algorithm and the Use of Micro-CT for Tissue Analysis

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.

Study Overview

• Status: Unknown
• Conditions: Diffuse Interstitial Lung Disease
• Intervention / Treatment: Procedure: Advanced endoscopic imaging modalities

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Jonas Yserbyt, MD; Phone Number: +3216332211; Email: jonas.yserbyt@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Lung transplant recipients and diffuse interstitial lung disease without certain diagnosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung transplant recipients; Lung transplant recipients with diffuse parenchymal abnormalities subjected to advanced endoscopic imaging modalities	Procedure: Advanced endoscopic imaging modalities; Virtual bronchoscopic navigation, confocal laser endomicroscopy, micro CT
Diffuse intersitial lung disease; Patients suffering from diffuse intersitial lung disease without a certain diagnosis subjected to advanced endoscopic imaging modalities	Procedure: Advanced endoscopic imaging modalities; Virtual bronchoscopic navigation, confocal laser endomicroscopy, micro CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic yield	postprocedural

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Jonas Yserbyt, MD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): May 25, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 150302V02