We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT01204970
Recruitment Status : Completed
First Posted : September 20, 2010
Last Update Posted : December 30, 2016
Information provided by (Responsible Party):
Marc Decramer, KU 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.

Layout table for study information
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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 ClinicalTrials.gov identifier (NCT number): NCT01204970

Layout table for location information
University Hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
KU Leuven
Layout table for investigator information
Principal Investigator: Jonas Yserbyt, MD Universitaire Ziekenhuizen KU Leuven
Principal Investigator: Chistophe Dooms, MD, PhD Universitaire Ziekenhuizen KU Leuven
Study Chair: Marc Decramer, MD, PhD Universitaire Ziekenhuizen KU Leuven
Study Chair: Geert Verleden, Md, PhD Universitaire Ziekenhuizen KU Leuven
Study Chair: Wim Janssens, MD, PhD Universitaire Ziekenhuizen KU Leuven
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Marc Decramer, Prof. Dr., KU Leuven
ClinicalTrials.gov Identifier: NCT01204970    
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, KU Leuven:
Confocal Laser Scanning Microendoscopy
Small airways
Lung transplantation
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases