Comparison of Lung Volume Reduction Surgery Versus Bronchoscopic Lung Volume Reduction in Patients With Homogenous Emphysema: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in FEV1 compared to baseline (deltaFEV1)
研究概览
简要总结
This is a prospective randomized clinical trial comparing surgical and bronchoscopic lung volume reduction in patients with advanced homogeneous emphysema suitable for both procedures.
详细描述
Lung volume reduction surgery (LVRS) as well as bronchoscopic lung volume reduction (BLVR) provide functional improvements in selected patients with homogenous emphysema and pronounced hyperinflation. A direct comparison of LVRS and BLVR in patients with homogenous emphysema is not available, thus the study will provide important data to guide treatment selection in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD III-IV
- •Age ≥ 18 years
- •FEV1 < 50% predicted after bronchodilatation
- •Significant hyperinflation (TLC >100% predicted, RV > 200% predicted, RV/TLC > 60%)
- •Non-smoker or ex-smoker for > 3 months (documented by cotinine testing)
- •6 MWT >150 m and ≤ 450m
- •MRC dyspnea score > 3
- •Homogenous emphysema as assessed by HR-CT (< 15% difference in emphysema destruction score between target lobe and ipsilateral lobe) [16, 17]
- •Uni- or bilateral collateral ventilation (CV) negative result assessed fissure completeness>95% in QCT and confirmed by a bronchoscopic procedure (Chartis©)
- •Optimal medical therapy for > 3months, sufficient rehabilitation status with no need for further training/rehabilitation or rehabilitation within 6 months prior to intervention.
- •Body Mass Index (BMI) > 18, but < 35 kg/m2
- •Daily dose of prednisone ≤ 10mg
排除标准
- •Contraindication against either LVRS or BLVR and/or to surgery and bronchoscopy in general
- •Major comorbidities limiting survival
- •Age ≥ 80 years
- •Nicotine abuse within 3 months (documented by cotinine testing)
- •Predominance of either left or right lung of >70% in perfusion SPECT scintigraphy
- •FEV1 and/or DLCO <20% predicted (post bronchodilatation)
- •Untreated Hypoxemia (PaO2 < 50 mmHg)
- •Untreated Hypercapnia (PaCO2 > 50 mmHg)
- •Significant pulmonary fibrosis or bronchiectasis
- •Destroyed/vanished lung on HR-CT
- •Previous chest surgery or bronchoscopic interventions
- •Pulmonary hypertension (sPAP > 35 mmHg)
- •Active waiting list for lung transplantation
- •Patient is not able to understand and willing to sign a written informed consent document.
- •Pregnancy
研究组 & 干预措施
Lung volume reduction surgery arm
Bilateral videothoracoscopic lung volume reduction surgery by wedge resection. Unilateral procedures are possible in case of severe adhesions or intraoperative instability. In these cases a staged approach with contralateral LVRS within 3 months is possible.
干预措施: Lung volume reduction surgery (Procedure)
Bronchoscopic lung volume reduction arm
Primarily unilateral bronchoscopic lung volume reduction by endobronchial valves. If a bilateral procedure is feasible it must be performed within 3 months after the first intervention.
干预措施: Bronchoscopic lung volume reduction (Procedure)
结局指标
主要结局
Change in FEV1 compared to baseline (deltaFEV1)
时间窗: 6 months post intervention
Percent change in FEV1
次要结局
- Change in BODE Index (Body mass index, airflow obstruction, dyspnoea and exercise capacity in chronic obstructive pulmonary disease)(3, 6 months post intervention)
- Change in TLC(3, 6 months post intervention)
- Change in RV(3, 6 months post intervention)
- Change in RV/TLC(3, 6 months post intervention)
- Change in DLCO(3, 6 months post intervention)
- Change in systolic pulmonary artery pressure(6 months post intervention)
- Changes in health-related quality of life measured by SGRQ(3, 6 months post intervention)
- Changes in respiratory health status measured by CAT(3, 6 months post intervention)
- Mortality(30 days post intervention)
- Overall survival(6 months post intervention)
- Incidence of (serious) adverse events(Periprocedural, 1, 3, 6 months post intervention)
研究者
Clemens Aigner
Professor of Thoracic Surgery
Universität Duisburg-Essen