Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage change in FEV1 relative to baseline
研究概览
简要总结
The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:
Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves?
Participants will:
undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.
receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria;
- •2. Age range from 40 to 85 years old (including 40 and 85 years old);
- •3. BMI ≤ 35kg/m2;
- •4. 15% ≤ FEV1% pred ≤ 45%;
- •5. TLC>100% pred, RV>140% pred, and DLCO/red% ≥ 20%;
- •6. 100m ≤ 6WMD ≤ 500m after rehabilitation training;
- •7. Quit smoking for more than 4 months;
- •8. The evaluation result of pulmonary bypass ventilation function is negative;
- •9. Participants in this clinical trial requires the signing of an informed consent form by the individual or legal representative.
排除标准
- •1. Being pregnant or breastfeeding;
- •2. PaCO2>50mmHg and/or PaO2<45mmHg;
- •3. Obvious bronchiectasis or other infectious lung diseases;
- •4. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;
- •5. Coagulation dysfunction, platelet count<60e+09/L;
- •6. Myocardial infarction or congestive heart failure within the past 24 weeks;
- •7. Previous lobectomy, LVRS or lung transplantation;
- •8. Anticoagulant therapy that cannot be stopped before surgery;
- •9. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure>45mmHg) or lungs diagnosed within the past 12 weeks Arterial hypertension;
- •10. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;
- •11. Pulmonary nodules that require intervention;
- •12. Patients participating in other clinical trials;
- •13. Individuals with other contraindications to bronchial operations;
- •14. Other circumstances that the researcher deems unsuitable for participation in this clinical trial.
结局指标
主要结局
Percentage change in FEV1 relative to baseline
时间窗: 12 weeks after surgery
The patient will undergo lung function tests.
次要结局
- Percentage change in SGRQ score relative to baseline(12 weeks after surgery)
- Percentage change in RV relative to baseline(12 weeks after surgery)
- Percentage change in TLC relative to baseline(12 weeks after surgery)
- Percentage change in 6MWD relative to baseline(12 weeks after surgery)
- the incidence of surgical-related adverse events(12 weeks after surgery)
- Percentage change in DLCO relative to baseline(12 weeks after surgery)
- Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators(12 weeks after surgery)
- Percentage change in mMRC grade relative to baseline(12 weeks after surgery)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital