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

December 29, 2016 updated by: Marc Decramer, KU Leuven

Confocal Laser Micro-endoscopy: New Insights in COPD and Lung Transplant Recipients

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
COPD
COPD Gold class 1-4
Transplant
Lung transplant recipients
Control
Patients with normal spirometric data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphometry
Time Frame: 90 - 180 - 360 - 540 - 720 days
morpohometrical analysis at different time point after lung transplantation
90 - 180 - 360 - 540 - 720 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: 90 - 180 - 360- 540- 720 days
bleeding, pneumothorax, pleuritic chest pain during procedure
90 - 180 - 360- 540- 720 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

September 17, 2010

First Posted (Estimate)

September 20, 2010

Study Record Updates

Last Update Posted (Estimate)

December 30, 2016

Last Update Submitted That Met QC Criteria

December 29, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B32220109292

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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