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

NCT01204970 | Completed

• 1 other identifier: B32220109292
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation; Chronic Obstructive Pulmonary Disease

Keywords

Confocal Laser Scanning Microendoscopy; Small airways; COPD; Lung transplantation

Outcome Measures

Primary Outcomes (1)

• morphometry

  morpohometrical analysis at different time point after lung transplantation

  90 - 180 - 360 - 540 - 720 days

Secondary Outcomes (1)

• adverse events

  90 - 180 - 360- 540- 720 days

Study Arms (3)

COPD

COPD Gold class 1-4

Transplant

Lung transplant recipients

Control

Patients with normal spirometric data

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• referral for bronchoscopic investigation/sampling
• informed consent signed
• recent spirometric data

You may not qualify if:

• sedated and/or ventilated patients
• patients on ICU
• patients under oral anticoagulation
• co-existing lung disease
• acute infectious pulmonary disease

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Yserbyt J, Dooms C, Janssens W, Verleden GM. Endoscopic advanced imaging of the respiratory tract: exploring probe-based confocal laser endomicroscopy in emphysema. Thorax. 2018 Feb;73(2):188-190. doi: 10.1136/thoraxjnl-2016-209746. Epub 2017 Apr 14.

  PMID: 28411249 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonas Yserbyt, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Chistophe Dooms, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 20, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 30, 2016

Record last verified: 2016-12

Locations

BE (1)