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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01204970
Recruitment Status : Completed
First Posted : September 20, 2010
Last Update Posted : December 30, 2016
Information provided by (Responsible Party):
Marc Decramer, Katholieke Universiteit Leuven

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.

Condition or disease
Lung Transplantation Chronic Obstructive Pulmonary Disease

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.

Study Type : Observational
Actual Enrollment : 176 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Confocal Laser Micro-endoscopy: New Insights in COPD and Lung Transplant Recipients
Study Start Date : September 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

COPD Gold class 1-4
Lung transplant recipients
Patients with normal spirometric data

Primary Outcome Measures :
  1. morphometry [ Time Frame: 90 - 180 - 360 - 540 - 720 days ]
    morpohometrical analysis at different time point after lung transplantation

Secondary Outcome Measures :
  1. adverse events [ Time Frame: 90 - 180 - 360- 540- 720 days ]
    bleeding, pneumothorax, pleuritic chest pain during procedure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01204970

University Hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Principal Investigator: Jonas Yserbyt, MD University Hospitals Leuven
Principal Investigator: Chistophe Dooms, MD, PhD University Hospitals Leuven
Study Chair: Marc Decramer, MD, PhD University Hospitals Leuven
Study Chair: Geert Verleden, Md, PhD University Hospitals Leuven
Study Chair: Wim Janssens, MD, PhD University Hospitals Leuven

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Marc Decramer, Prof. Dr., Katholieke Universiteit Leuven Identifier: NCT01204970     History of Changes
Other Study ID Numbers: B32220109292
First Posted: September 20, 2010    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016

Keywords provided by Marc Decramer, Katholieke Universiteit Leuven:
Confocal Laser Scanning Microendoscopy
Small airways
Lung transplantation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases