Efficacy and Safety of 0.5% w/v Nano- Silver Nitrate Versus Silver Nitrate Solution for Bronchoscopic Lung Volume Reduction in Management of Localized Emphysema: Prospective Interventional Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Residual volume/ Total lung capacity (RV/TLC) ratio and volumetry
研究概览
简要总结
Emphysema is a progressive phenotype of chronic Obstructive Pulmonary Disease (COPD), poses a significant global health burden characterized by irreversible lung parenchymal destruction and airspace enlargement.
In recent years, bronchoscopic lung volume reduction (BLVR) has considerable interest as a minimally invasive approach to reducing hyperinflation and improving lung function in patients with emphysema.
BLVR techniques aim to achieve lung volume reduction by occluding or ablating emphysematous lung tissue through endobronchial delivery of various agents. Many techniques are available for BLVR as coil, endo-bronchial valve, and biological as thrombin, autologous blood and chemicals as silver nitrate solution.
详细描述
Emphysema is a progressive phenotype of chronic Obstructive Pulmonary Disease (COPD), poses a significant global health burden characterized by irreversible lung parenchymal destruction and airspace enlargement.
In recent years, bronchoscopic lung volume reduction (BLVR) has considerable interest as a minimally invasive approach to reducing hyperinflation and improving lung function in patients with emphysema.
BLVR techniques aim to achieve lung volume reduction by occluding or ablating emphysematous lung tissue through endobronchial delivery of various agents. Many techniques are available for BLVR as coil, endo-bronchial valve, and biological as thrombin, autologous blood and chemicals as silver nitrate solution.
Chemical lung volume reduction is an endo-bronchial approach, which uses chemical agents aiming to reduce lung volume by blocking off the most emphysematous areas with a rapidly polymerizing sealant. Endobronchial Valves (EBVs) show an overall success rate of 70-80% in reducing lung volume and improving lung function. Lung volume reduction coils (LVRC-Coils) have a success rate of 50-60%.
Bronchoscopic lung volume reduction with silver nitrate as a chemical agent was used in previous studies using a concentration of 0.5% and showed significant improvement in forced expiratory volume in first second (FEV1), diffusion capacity of lung to carbon monoxide (DLCo), modified Medical Research Council (mMRC) score when compared to base line values and reduction of the High Resolution Computed Tomography (HRCT) volumetry of the emphysematous regions.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD of grade III and IV according to GOLD 2024 staging of COPD with localized (heterogeneous) emphysema as determined by high resolution computerized tomography (HRCT) of the chest with area of destruction >-950 Hounsfield units (HU) and respiratory symptoms despite optimal medical therapy with the following criteria: Patient less than 75 years of age not candidate for or had refused lung volume reduction surgery but fit for fibro-optic bronchoscope (FOB). Lung volumes criteria: FEV1 less than 60% of predicted value, Residual volume (RV) more than 100% of predicted value, Total lung capacity (TLC) more than 100% of predicted value, 6 MWT of less than 450 meters.
排除标准
- •Significant co-morbidities that limits exercise capacity or prognosis as cardiovascular diseases (heart failure, arrhythmia, ischemic heart disease) and lung cancer.
- •Patients unfit or refused FOB.
- •Homogenous emphysema.
- •More than 75 years of age.
- •Associated lung fibrosis.
- •FEV1 > 60%.
- •Current smoker.
研究组 & 干预措施
0.5%w/v Nano- silver nitrate solution
0.5% weight by volume(w/v) Nano- silver nitrate solution for bronchoscopic lung volume reduction in management of localized emphysema
干预措施: Nano-silver nitrate (Drug)
0.5%w/v Nano- silver nitrate solution
0.5% weight by volume(w/v) Nano- silver nitrate solution for bronchoscopic lung volume reduction in management of localized emphysema
干预措施: Bronchoscopic lung volume reduction (Device)
0.5%w/v silver nitrate solution
0.5%w/v silver nitrate solution for bronchoscopic lung volume reduction in management of localized emphysema
干预措施: Silver Nitrate (Drug)
0.5%w/v silver nitrate solution
0.5%w/v silver nitrate solution for bronchoscopic lung volume reduction in management of localized emphysema
干预措施: Bronchoscopic lung volume reduction (Device)
结局指标
主要结局
Residual volume/ Total lung capacity (RV/TLC) ratio and volumetry
时间窗: 6 months
RV/TLC ratio measured at 6 months following treatment. Treatment success is defined as a statistically significant reduction in RV/TLC and from baseline.
change in Forced expiratory volume at first second (FEV1) and Forced vital capacity (FVC)
时间窗: 6 months
change from baseline to 6 months in FEV1 and FVC,
Voluometry
时间窗: 6 months
Voluometry measured at 6 months following treatment. Treatment success is defined as a statistically significant reduction in voluometry and from baseline.
diffusing capacity of the lung for carbon monoxide (DLCO)
时间窗: 6 months
change from baseline to 6 months in diffusing capacity of the lung for carbon monoxide (DLCO)
次要结局
未报告次要终点
研究者
Mohamed Abd Elmoniem Mohamed
Lecturer of chest medicine
Mansoura University Hospital