Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium (BEVA)

Catholic University (KU) of Leuven

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Procedure: Lung volume reduction surgery (LVRS); Behavioral: physical activity tele coaching; Device: endobronchial valves

Study type: Interventional

Funder types: Other

Identifiers

NCT03264768

s60207

Details and patient eligibility

About

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

Full 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.

.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

control

Other group

Description:

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

Treatment:

Procedure: Lung volume reduction surgery (LVRS)

Behavioral: physical activity tele coaching

Endobronchial valves

Experimental group

Description:

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

Treatment:

Procedure: Lung volume reduction surgery (LVRS)

Device: endobronchial valves

Behavioral: physical activity tele coaching