emphysema
Conditions
Interventions
Bronchoscopic thermal vapor ablation treatment group:Bronchoscopic thermal vapor ablation
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 40 to 75 years old; 2. Heterogeneous emphysema with upper lobe predominance in both lungs, per high-resolution computed tomography (HRCT) measured Heterogeneity Index >1.2FEV1 between 20% and 45% predicted; 3. Total lung capacity (TLC) > 100% predicted; 4. Residual volume (RV) > 150% predicted; 5. Post-rehabilitation 6-minute walk test >140 meters; 6. With or without asthma, or with/without airway hyperresponsiveness (Bronchial provocation test is positive); 7. Marked dyspnea scoring > 2 on the modified Medical Research Council scale (mMRC); 8. Arterial blood gas PaCO2 = 50 mm Hg; PaO2 > 50 mm Hg on room air; 9. Non-smoking for 2 months prior to study enrollment, as confirmed by negative urine or serum cotinine level of = 10 ng/mL, or negative COHb test,and willing to quit smoking during the entire study; 10. Optimized medical management (treatment consistent with GOLD guidelines); 11. Complete pulmonary rehabilitation for at least 3 months prior to study enrollment; 12. Inoculated with flu vaccine; 13. Mentally and physically able to cooperate with the study procedures, follow-up requirements, and are able and willing to provide informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Any condition that would interfere with the completion of the study,follow-up assessments, bronchoscopy, or that would adversely affect study outcomes. Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of particular relevance include immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha 1 antitrypsin; 2. DLCO 32 kg/m2; 4. Homogeneous disease and/or with highly diseased lower lobes (tissue to air ratio of 3 COPD related hospitalizations requiring antibiotics in past 12 months; COPD related hospitalization in past 3 months; daily use of systemic steroids, i.e. > 5 mg prednisolone; 10. History of any of the following: Left ventricular ejection fraction (EF) = 40%; Stroke; Myocardial infarction or acute coronary syndrome in previous year; Hospitalization due to left ventricular failure in previous 3 years; Coagulopathy or current use of anticoagulants (including coumadin, dabigatran); Known sensitivity to medications required to perform bronchoscopy; 11. Pulmonary hypertension:Peak systolic: PAP > 45 mm Hg or Mean PAP > 35 mm Hg or Right heart catheter measurements will be considered definitive over echocardiogram measurements; 12. Newly prescribed Morphine derivatives within the last 4 weeks; 13. Pregnant or breastfeeding; 14. Current enrollment in any other investigational study which has not completed requisite follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radionuclide Ventilation/Perfusion Imaging;Serious Adverse Events (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Pulmonary Function;St. George's Respiratory Questionnaire (SGRQ);COPD Exacerbations;Chest Imaging;Six-Minute Walk Test (6MWT); | — |
Countries
China
Contacts
Public ContactHui Zhu
West China Hospital, Sichuan University
Outcome results
None listed