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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204970
• Other study ID #: B32220109292
• Status: Completed
• Phase: N/A
• First received: September 17, 2010
• Last updated: December 29, 2016
• Start date: September 2010
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Lung Transplantation
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphometry	morpohometrical analysis at different time point after lung transplantation	90 - 180 - 360 - 540 - 720 days	No
Secondary	adverse events	bleeding, pneumothorax, pleuritic chest pain during procedure	90 - 180 - 360- 540- 720 days	Yes