Ventilation-Perfusion Discrepancy Index Versus Conventional Anatomic-Physiologic Assessment for Target Lung Lobe Selection in Endobronchial Valve Placement: A Multicenter, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Ventilation-Perfusion Discrepancy Index (VQDI)
研究概览
简要总结
The goal of this clinical trial is to learn if a Ventilation-Perfusion Discrepancy Index (VQDI)-guided strategy for selecting the target lung lobe can improve outcomes compared to the standard strategy in patients with severe emphysema undergoing bronchoscopic lung volume reduction with endobronchial valves (EBVs).
The main question it aims to answer is:
· Does selecting the target lobe based on the lowest VQDI (indicating the worst functional mismatch) lead to a higher rate of successful treatment response at 6 months compared to selecting the lobe based on the worst destruction on CT scan?
If there is a comparison group: Researchers will compare the VQDI-guided selection group to the conventional CT/Chartis-guided selection group to see which strategy results in more patients achieving significant improvement in both lung function and reduction in the size of the treated lobe.
Participants will:
- Undergo standard clinical assessments (lung function tests, CT scan, exercise test) and an additional V/Q SPECT/CT scan to calculate the VQDI.
- Have their collateral ventilation status checked using the Chartis system during bronchoscopy.
- Be randomly assigned to one of the two target lobe selection strategies.
- Receive EBV placement in the selected lobe.
- Attend follow-up visits at 1, 3, 6, and 12 months after the procedure for check-ups, repeated lung function tests, questionnaires, and CT scans to assess their response to treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological evidence of emphysema
- •Nonsmoking for 4 months prior to screening interview
- •BMI less than 35 kg/m2
- •Stable on current medication regimen
- •Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
- •Residual Volume less than 175% predicted (determined by body plethysmography)
- •Little or no collateral ventilation (CV-) as determined using the Chartis System
排除标准
- •Had two or more hospitalizations over the last year for a COPD exacerbation
- •Had two or more hospitalizations over the last year for pneumonia
- •Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
- •Had a heart attack or congestive heart failure within the last 6 months
- •Have heart arrhythmia
- •Is alpha-1 antitrypsin deficient
研究组 & 干预措施
VQDI-assisted target lung lobe selection strategy
Target lobe selection is based on the lobe with the lowest VQDI among all lobes with an absence of collateral ventilation (Chartis-negative), indicating the most severe ventilation-perfusion mismatch.
干预措施: VQDI-assisted target lung lobe selection strategy (Procedure)
Conventional target lung lobe selection strategy
Target lobe selection is based on the lobe with the highest CT destruction score among all lobes with an absence of collateral ventilation (Chartis-negative), indicating the most severe anatomical destruction.
干预措施: Conventional target lung lobe selection strategy (Procedure)
结局指标
主要结局
Ventilation-Perfusion Discrepancy Index (VQDI)
时间窗: 6 month
The absolute change in the target lobe's VQDI from baseline to 6 months post-procedure.
次要结局
- St. George's Respiratory Questionnaire (SGRQ)(1 year)
- FEV1 Post-bronchodilator Absolute Change(1 year)
- 6-minute Walk Distance(1 year)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital