Clinical trial NCT06349174: Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
Official title: Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emphysema
Chronic Obstructive Pulmonary Disease
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:

Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves?

Participants will:

undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.

receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.


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.

Primary outcomes:
measure: Percentage change in FEV1 relative to baseline
timeFrame: 12 weeks after surgery
Secondary outcomes:
measure: Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators
timeFrame: 12 weeks after surgery
measure: Percentage change in RV relative to baseline
timeFrame: 12 weeks after surgery
measure: Percentage change in TLC relative to baseline
timeFrame: 12 weeks after surgery
measure: Percentage change in DLCO relative to baseline
timeFrame: 12 weeks after surgery
measure: Percentage change in SGRQ score relative to baseline
timeFrame: 12 weeks after surgery
measure: Percentage change in mMRC grade relative to baseline
timeFrame: 12 weeks after surgery
measure: Percentage change in 6MWD relative to baseline
timeFrame: 12 weeks after surgery
measure: the incidence of surgical-related adverse events
timeFrame: 12 weeks after surgery
Other outcomes:
Locations:
city: BeiJing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References: