Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study

Launched by CHINA-JAPAN FRIENDSHIP HOSPITAL · Mar 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for patients with emphysema and chronic obstructive pulmonary disease (COPD). The researchers want to see if a special device called endobronchial valves, used during a type of surgery aimed at reducing lung volume, can help improve breathing, exercise ability, and symptoms in patients. They will also monitor any side effects that participants may experience from the surgery. Participants will need to meet certain criteria, such as being between 40 and 85 years old, having specific measures of lung function, and being non-smokers for at least four months.

If you or a loved one joins this study, you will undergo the surgery using these valves, and your health will be monitored closely before the procedure and then again at three days, four weeks, and twelve weeks after surgery. This is a chance to help researchers learn more about this treatment, which could potentially improve the quality of life for people with COPD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria;
• • 2. Age range from 40 to 85 years old (including 40 and 85 years old);
• • 3. BMI ≤ 35kg/m2;
• • 4. 15% ≤ FEV1% pred ≤ 45%;
• • 5. TLC\>100% pred, RV\>140% pred, and DLCO/red% ≥ 20%;
• • 6. 100m ≤ 6WMD ≤ 500m after rehabilitation training;
• • 7. Quit smoking for more than 4 months;
• • 8. The evaluation result of pulmonary bypass ventilation function is negative;
• • 9. Participants in this clinical trial requires the signing of an informed consent form by the individual or legal representative.
• Exclusion Criteria:
• • 1. Being pregnant or breastfeeding;
• • 2. PaCO2\>50mmHg and/or PaO2\<45mmHg;
• • 3. Obvious bronchiectasis or other infectious lung diseases;
• • 4. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;
• • 5. Coagulation dysfunction, platelet count\<60e+09/L;
• • 6. Myocardial infarction or congestive heart failure within the past 24 weeks;
• • 7. Previous lobectomy, LVRS or lung transplantation;
• • 8. Anticoagulant therapy that cannot be stopped before surgery;
• • 9. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure\>45mmHg) or lungs diagnosed within the past 12 weeks Arterial hypertension;
• • 10. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;
• • 11. Pulmonary nodules that require intervention;
• • 12. Patients participating in other clinical trials;
• • 13. Individuals with other contraindications to bronchial operations;
• • 14. Other circumstances that the researcher deems unsuitable for participation in this clinical trial.