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

Completed

• Conditions: Lung Transplantation; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01204970
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-17
• Study First Posted: 2010-09-20
• Primary Completion: 2016-07
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-29
• Last Update Posted: 2016-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
morphometry	90 - 180 - 360 - 540 - 720 days	morpohometrical analysis at different time point after lung transplantation

Secondary Outcome Measures

Name	Time	Method
adverse events	90 - 180 - 360- 540- 720 days	bleeding, pneumothorax, pleuritic chest pain during procedure

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium