Severe Emphysema
Conditions
Keywords
Bronchoscopic Thermal Vapor Ablation (BTVA), Chronic obstructive pulmonary disease (COPD), Severe emphysema, Bronchoscopic lung volume reduction (BLVR)
Brief summary
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
Interventions
PROCEDUREBTVA treatment plus optimal medical therapy (GOLD guidelines)
Patients in experimental group will be treated with the InterVapor System in at least 2 subsegments of different segments(unless the two most severe subsegments are located in the same segment). Patients in control group will be treated with the InterVapor System in at least 1 segment. A sequential procedure allows for at least 6 weeks and no longer than 6 months after the first procedure. Patients in both groups will receive ipsilateral hemithorax treatment per procedure, with a treatment volume (air + tissue) of ≤1700 mL per procedure and ≥1000 mL cumulatively across two procedures. All patients will continue to receive optimal medical therapy (GOLD guidelines) for the duration of the study. Follow-up visits will be scheduled at 1, 3, 6 and 12 months following the second procedure with examination of pulmonary function tests, HRCT, 6-minute walk test, SGRQ-C, mMRC, CAT questionnaires. All adverse events during the study will be recorded.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18 years old; 2. Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT; 3. Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study; 4. 15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%); 5. 6MWD \>140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test) 6. mMRC score≥2; 7. Arterial blood gas levels of: PaCO2≤55 mmHg; PaO2\>50 mmHg on room air; 8. Mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment.
Exclusion criteria
1. Contraindications to bronchoscopy, such as: Prior myocardial infarction within 1 month, unstable myocardial ischaemia, ejection fraction (EF) ≤ 40%; Active haemoptysis; Coagulation disorders; Malignant cardiac arrhythmia, severe pulmonary hypertension, extreme systemic failure, etc; 2. 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 deficiency; 3. Use of morphine derivatives within 4 weeks prior to screening; 4. Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit; 5. Recent COPD exacerbation in preceding 6 weeks; 6. Severe emphysema in both the upper and lower lobes of the contralateral lungs, defined as %LAA-950 assessed by HRCT as a percentage of whole lung lobe volume \> 40%; 7. Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe; 8. Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.); 9. History of heart and/or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, thoracic surgery with removal of lung tissue and endobronchial lung volume reduction (via valves, coils, stents, etc.); 10. Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist; 11. Pregnant or breastfeeding; 12. Current enrollment in any other investigational study which has not completed requisite follow-up; 13. Any conditions assessed by investigator that make patients inappropriate for enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in FEV1 | 6 months following the second procedure | Improvement in FEV1 between experimental group vs control group at 6 months following the second procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in mMRC | 6 and 12 months following the second procedure | Changes in mMRC from baseline at 6,12 months |
| Changes in lung volumes by HRCT | 6 and 12 months following the second procedure | Changes in lung volumes from baseline as assessed by HRCT at 6,12 months |
| Changes in FEV1 | 12 months following the second procedure | Changes in FEV1 from baseline at 12 months |
| Changes in Quality-of-Life score | 6 and 12 months following the second procedure | Changes in Quality-of-Life score as assessed by the SGRQ-C questionnaire from baseline at 6,12 months |
| Changes in FVC | 6 and 12 months following the second procedure | Changes in FVC from baseline at 6,12 months |
| Changes in RV | 6 and 12 months following the second procedure | Changes in RV from baseline at 6,12 months: RV |
| Changes in CAT | 6 and 12 months following the second procedure | Changes in CAT from baseline at 6,12 months |
| Changes in RV/TLC | 6 and 12 months following the second procedure | Changes in RV/TLC from baseline at 6,12 months |
| Changes in DLCO | 6 and 12 months following the second procedure | Changes in DLCO from baseline at 6,12 months |
| Changes in 6MWD | 6 and 12 months following the second procedure | Changes in 6MWD from baseline at 6,12 months (patients with lower limb disability or motor dysfunction will be exempted from the test) |
| A binary responder rate analysis will be performed to determine Minimal Clinically Important Difference (MCID) | 6 and 12 months following the second procedure | A binary responder rate analysis will be performed to determine Minimal Clinically Important Difference (MCID) at 6,12 months: %predicted FEV1≥12% difference from baseline SGRQ-C≥8 points difference from baseline 6MWD≥26m from baseline |
| Incidence of Adverse Events | during or within 12 months after the operation | Adverse events related to the procedure during or within 12 months after the operation |
| Changes in TLC | 6 and 12 months following the second procedure | Changes in TLC from baseline at 6,12 months |
Countries
China
Contacts
Primary ContactJiayuan Sun, MD., PhD.
Backup ContactHuan Hou, MD., PhD.
Outcome results
None listed