Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium

NCT ID: NCT03264768

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-12-31

Brief Summary

This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves

Detailed Description

The primary objective of the current study is to explore the effect of targeted lobar endobronchial lung volume reduction in symptomatic patients with severe emphysema and absent collateral ventilation, on lung function, exercise capacity and physical activity. As a secondary objective, changes in physical activity as result of a 3 month activity coaching program delivered between 3 to 6 months post intervention will be investigated. Exploratory objectives are to extend insight in the clinical characteristics of responders and non-responders and to address relationships between lung function response, physical functioning and its impact on inflammation, skeletal and cardiac function. Furthermore, comparison of the effects on lung function, exercise capacity, quality of life and physical activity between endoscopic lung volume reduction and surgical lung volume reduction will be made.

The study will also explore if treatment response can be optimised by an intermediate evaluation with CT scan one month after intervention. Endoscopic evaluation and repositioning of the endobronchial valves will be imposed in case no lober atelectasis is visualised.

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Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control

standard care in case collateral ventilation is observed (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post allocation.

Group Type: OTHER

physical activity tele coaching

Intervention Type: BEHAVIORAL

3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.

Lung volume reduction surgery (LVRS)

Intervention Type: PROCEDURE

Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.

Endobronchial valves

Endobronchial valves in case collateral ventilation is absent (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post intervention.

Group Type: EXPERIMENTAL

endobronchial valves

Intervention Type: DEVICE

A ambulatory diagnostic bronchoscopy under general anesthesia will evaluate the presence or absence of collateral ventilation . The targeted lobar airway is temporarily occluded by means of a balloon catheter, which blocks inspiratory flow but allows expiratory flow, in order to assess whether the air flow gradually declines to zero, meaning absence of collateral ventilation. Only in case collateral ventilation is excluded, a therapeutic bronchoscopy will be scheduled to insert the one-directional endobronchial valves in the targeted lobar airways. We will only perform a unilateral intervention during which we will treat one or maximal two lobes at one side.

physical activity tele coaching

Intervention Type: BEHAVIORAL

3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.

Lung volume reduction surgery (LVRS)

Intervention Type: PROCEDURE

Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.

Interventions

endobronchial valves

A ambulatory diagnostic bronchoscopy under general anesthesia will evaluate the presence or absence of collateral ventilation . The targeted lobar airway is temporarily occluded by means of a balloon catheter, which blocks inspiratory flow but allows expiratory flow, in order to assess whether the air flow gradually declines to zero, meaning absence of collateral ventilation. Only in case collateral ventilation is excluded, a therapeutic bronchoscopy will be scheduled to insert the one-directional endobronchial valves in the targeted lobar airways. We will only perform a unilateral intervention during which we will treat one or maximal two lobes at one side.

Intervention Type: DEVICE

physical activity tele coaching

3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.

Intervention Type: BEHAVIORAL

Lung volume reduction surgery (LVRS)

Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 40 - 75 years
• Confluent or destructive heterogeneous emphysema on CT
• Smoking cessation for at least 6m (proven by urinary cotinine levels)
• FEV1 < 60 %predicted, RV > 150 %predicted, TLC > 90 %predicted
• RV/TLC ratio ≥ 0.55
• 6MWD < 450 meter
• mMRC ≥ 2
• Visual estimation of 70% complete fissure between target lobe and adjacent lobe on CT of referring physician
• LABA-LAMA bronchodilator therapy as a minimum therapy
• Able to sign informed consent

Exclusion Criteria

• Homogenous emphysema
• PaCO2 > 60 mmHg with ambient air
• PaO2 < 45 mmHg with ambient air
• Previous LVRS, lung transplantation, lobectomy
• TLCO or FEV1 < 20% predicted
• Significant pulmonary hypertension (PaPsyst > 50 mm Hg)
• Heart failure with reduced EF (< 40%)
• 6MWD < 100 meter
• BODE index ≥ 7 and eligible for transplantation
• Active cancer
• Life expectancy < 3 months
• Significant lung disease other than COPD/emphysema
• Unable to comply with study procedures

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Wim Janssens

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wim Janssens, MD

Role: PRINCIPAL_INVESTIGATOR

University hospital Leuven, Belgium

Dooms Christophe, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospial Leuven, Belgium

Locations

UZ Leuven

Leuven, Flanders, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Karen Denaux, sc, nurse

Role: CONTACT

karen.denaux@uzleuven.be

016 34 19 66 ext. 0032

Kristien De Bent, sc

Role: CONTACT

krisiten.debent@uzleuven.be

016 34 17 01 ext. 0032

Other Identifiers

s60207

Identifier Type: -

Identifier Source: org_study_id