Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients

NCT ID: NCT01204970

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Lung Transplantation Chronic Obstructive Pulmonary Disease

Keywords

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Confocal Laser Scanning Microendoscopy Small airways COPD Lung transplantation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD

COPD Gold class 1-4

No interventions assigned to this group

Transplant

Lung transplant recipients

No interventions assigned to this group

Control

Patients with normal spirometric data

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Marc Decramer

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonas Yserbyt, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Chistophe Dooms, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Marc Decramer, MD, PhD

Role: STUDY_CHAIR

Universitaire Ziekenhuizen KU Leuven

Geert Verleden, Md, PhD

Role: STUDY_CHAIR

Universitaire Ziekenhuizen KU Leuven

Wim Janssens, MD, PhD

Role: STUDY_CHAIR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 28411249 (View on PubMed)

Other Identifiers

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B32220109292

Identifier Type: -

Identifier Source: org_study_id