Emphysema
Conditions
Keywords
Endobronchial Lung Volume Reduction, Ventilation-Perfusion Discrepancy Index, Emphysema, Chronic Obstructive Pulmonary Disease
Brief summary
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.
Interventions
PROCEDUREVQDI-assisted target lung lobe selection strategy
Participants in this arm undergo endobronchial valve (EBV) placement in a target lobe selected specifically based on functional imaging. Among all lobes confirmed to have no collateral ventilation (assessed by the Chartis system), the lobe with the lowest Ventilation-Perfusion Discrepancy Index (VQDI) - indicating the most severe mismatch between air flow and blood flow - is chosen for treatment. All other procedural aspects, screening assessments, and follow-up are identical to the comparator arm.
PROCEDUREConventional target lung lobe selection strategy
Participants in this arm undergo endobronchial valve (EBV) placement in a target lobe selected based on standard anatomical criteria. Among all lobes confirmed to have no collateral ventilation (assessed by the Chartis system), the lobe with the highest CT destruction score - indicating the most severe anatomical emphysema - is chosen for treatment. This reflects current standard-of-care practice. All other procedural aspects, screening assessments, and follow-up are identical to the experimental arm.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilation-Perfusion Discrepancy Index (VQDI) | 6 month | The absolute change in the target lobe's VQDI from baseline to 6 months post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| St. George's Respiratory Questionnaire (SGRQ) | 1 year | Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline). The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations. |
| FEV1 Post-bronchodilator Absolute Change | 1 year | Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline). |
| 6-minute Walk Distance | 1 year | Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline). |
Countries
China
Contacts
CONTACTMingming Deng, Ph.D., M.D.
Outcome results
None listed