Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- KU Leuven
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- response rate of FEV1 at 3 months post intervention
Study Overview
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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Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
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.
Intervention: physical activity tele coaching (Behavioral)
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.
Intervention: Lung volume reduction surgery (LVRS) (Procedure)
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.
Intervention: endobronchial valves (Device)
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.
Intervention: physical activity tele coaching (Behavioral)
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.
Intervention: Lung volume reduction surgery (LVRS) (Procedure)
Outcomes
Primary Outcomes
response rate of FEV1 at 3 months post intervention
Time Frame: 3 months
proportion of patients with a minimal change of FEV1 \> 100 ml
Secondary Outcomes
- response rate on FEV1 at 6 months post intervention(6 months)
- response rate on SGRQ at 3 months and 6 months post intervention(3 months and 6 months post intervention)
- response rate on 6 minutes walking distance (6MWD) at 3 months and 6 months post intervention(3 months and 6 months post intervention)
- response rate on residual volume (RV) at 3 months and 6 months post intervention(3 months and 6 months post intervention)
- response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention(3 months and 6 months post intervention)
Investigators
Wim Janssens
Clinical Professor
KU Leuven