Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- response rate of FEV1 at 3 months post intervention
研究概览
简要总结
This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves
详细描述
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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研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: Lung volume reduction surgery (LVRS) (Procedure)
结局指标
主要结局
response rate of FEV1 at 3 months post intervention
时间窗: 3 months
proportion of patients with a minimal change of FEV1 \> 100 ml
次要结局
- 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)