Clinical trial NCT01204970: Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients
Official title: Confocal Laser Micro-endoscopy: New Insights in COPD and Lung Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Chronic Obstructive Pulmonary Disease
Keywords: Confocal Laser Scanning Microendoscopy
Small airways
COPD
Lung transplantation
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2010-09-20
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred for a bronchoscopic procedure will be asked to undergo CLME. 3 pools will be made: COPD patients according to their pulmonary function test, lung transplant recipients and patients with normal spirometric results. In all groups the difference between active smokers and no-smokers will be made.

Brief summary: Aspects of confocal laser micro-endoscopy (CLME) and morphometry in chronic obstructive pulmonary disease (COPD) and lung transplant recipients is described and will be correlated with clinical findings in order to described small airway remodelling in these patients.

Detailed description: In early phases of COPD, changes in small airway characteristics may develop. Elastin decay and matrix remodelling could be responsible for these changes. Using CLME changes of in the bronchiolar wall and alveolar ducts can be visualized, described and measured.

In lung transplant recipients, CMLE will be performed to distinguish characteristics of distal airways in stabile patient in contrast to patients with bronchiolitis obliterans syndrome.

In both groups data will be correlated with CT findings, pulmonary function tests and anatomopathological results.

Eligibility criteria: Inclusion Criteria:

* referral for bronchoscopic investigation/sampling
* informed consent signed
* recent spirometric data

Exclusion Criteria:

* sedated and/or ventilated patients
* patients on ICU
* patients under oral anticoagulation
* co-existing lung disease
* acute infectious pulmonary disease

Primary outcomes:
measure: morphometry
timeFrame: 90 - 180 - 360 - 540 - 720 days
Secondary outcomes:
measure: adverse events
timeFrame: 90 - 180 - 360- 540- 720 days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jonas Yserbyt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Chistophe Dooms, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Marc Decramer, MD, PhD
role: STUDY_CHAIR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Geert Verleden, Md, PhD
role: STUDY_CHAIR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Wim Janssens, MD, PhD
role: STUDY_CHAIR
References:
citation: Yserbyt J, Dooms C, Janssens W, Verleden GM. Endoscopic advanced imaging of the respiratory tract: exploring probe-based confocal laser endomicroscopy in emphysema. Thorax. 2018 Feb;73(2):188-190. doi: 10.1136/thoraxjnl-2016-209746. Epub 2017 Apr 14.