NCT04537182招募中不适用
Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema: an International Multi-center Randomized Controlled Trial
Isabelle Opitz, Professor, MD11 个研究点 分布在 4 个国家目标入组 120 人开始时间: 2020年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 11
- 主要终点
- Change from baseline value in FEV1 (ml)
研究概览
简要总结
The investigators plan to perform a randomized controlled trial that compares bilateral lung volume reduction surgery (LVRS) with bronchoscopic lung volume reduction (BLVR) using endobronchial valves in terms of efficacy and patient safety.
详细描述
Advanced lung emphysema has a considerable impact on quality of life in patients with chronic obstructive pulmonary disease. There are positive reports of surgical as well as bronchoscopic volume reduction in selected patients, but data comparing LVRS and BLVR is unfortunately lacking to date. The investigators therefore anticipate that their study will make an important contribution to the worldwide efforts in better understanding selection and management of surgical and bronchoscopic treatment of emphysema patients and that it will be of high public interest.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from emphysema (all morphologies, uni- or bilateral distribution) potentially qualifying for both study procedures, LVRS or BLVR (if possible, perfusion scintigraphy within < 6 month of screening, CT scan within < 4 months of screening)
- •Age ≥ 30 and ≤ 80 years
- •Body Mass Index (BMI) ≥ 16, but ≤ 35 kg/m2
- •Non-smoking for 3 months prior to screening interview
- •Patient is able to understand and willing to sign a written informed consent document.
排除标准
- •FEV1 more than 50% predicted
- •TLC less than 100 % predicted, RV less than 175% predicted, RV/TLC less than 58% predicted, and DLCO ≤ 20% predicted in homogeneous emphysema and DLCO ≤ 15% in heterogeneous emphysema, respectively
- •PaO2 ≤ 6.0 kPa (45mm Hg) at ambient air (only applicable for homogeneous morphology!)
- •PaCO2 ≥ 6.6 kPa (50 mmHg) at ambient air (only applicable for homogeneous morphology!)
- •Patients with incomplete interlobar fissures as revealed by quantitative computed tomography analysis with StratX® (fissure completeness ≤ 80%)
- •Patients with collateral ventilation as evidenced by bronchoscopic Chartis® measurement (only performed if fissure completeness according to StratX® is < 95%)
- •6-minute walking distance ≥ 470m
- •More than two COPD exacerbation episodes requiring hospitalization in the last year
- •More than two instances of pneumonia episodes in the last year
- •Unplanned weight loss ≥ 10% within 90 days prior to enrollment
- •Pulmonary hypertension as evidenced by Delta Psyst RV-RA > 35 mmHg on recent echocardiography (within 3 months prior to screening) and confirmed by RHC (mPAP ≥ 35 mmHg) and signs of moderate to severe RV dysfunction.
- •Evidence of left ventricular ejection fraction (LVEF) less than 45% on recent echocardiography (within 3 months prior to screening)
- •History of exercise-related syncope
- •Myocardial infarction or congestive heart failure within 6 months of screening
- •Clinically significant arrhythmias that might put the patient at risk in regard to the interventions
- •Prior LVR (any method), bullectomy, or lobectomy
- •Clinically significant bronchiectasis with expectoration of ≥ 2 tablespoons/day.
- •Pulmonary nodule requiring surgery
- •Unable to safely discontinue anticoagulants or dual antiplatelet therapy for 7 days
- •Patients with a life expectancy of less than one year
结局指标
主要结局
Change from baseline value in FEV1 (ml)
时间窗: 6 months after intervention
Percent change in FEV1
次要结局
- Change from baseline value in TLC(3, 6 and 12 months after intervention)
- Change from baseline value in 6-minute walking distance(3, 6 and 12 months after intervention)
- Change from baseline regarding pain (PDI score)(3, 6 and 12 months after intervention)
- Incidence of (serious) adverse events / re-interventions(3, 6 and 12 months after intervention)
- Change from baseline value in FEV1(3 and 12 months after intervention)
- Change from baseline value in mMRC dyspnea score(3, 6 and 12 months after intervention)
- Change from baseline in quality of life (SGRQ, EQ-5D-5L)(3, 6 and 12 months after intervention)
- Change from baseline value in RV(3, 6 and 12 months after intervention)
- Change from baseline value in RV/TLC(3, 6 and 12 months after intervention)
- Change from baseline value in DLCO(3, 6 and 12 months after intervention)
- Change from baseline regarding pain (VAS)(3, 6 and 12 months after intervention)
- 30-days mortality(1 month)
- 90-days mortality(3 months)
- Overall survival rate(12 months)
研究者
Isabelle Opitz, Professor, MD
Prof. MD
University of Zurich
研究点 (11)
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