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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06349174
• Other study ID #: 2024-valve-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 11, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: China-Japan Friendship Hospital
• Contact: Gang Hou, MD
• Phone: 010-84205729
• Email: hougangcmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 31, 2025
• Est. primary completion date: March 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• bronchoscopic lung volume reduction surgery using endobronchial valve
The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	BeiJing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in FEV1 relative to baseline	The patient will undergo lung function tests.	12 weeks after surgery
Secondary	Percentage of subjects with FEV1 improvement = 12% after bronchodilators	The patient will undergo lung function tests.	12 weeks after surgery
Secondary	Percentage change in RV relative to baseline	The patient will undergo lung function tests, and residual volume (RV) will be recorded.	12 weeks after surgery
Secondary	Percentage change in TLC relative to baseline	The patient will undergo lung function tests, and total lung capacity (TLC) will be recorded.	12 weeks after surgery
Secondary	Percentage change in DLCO relative to baseline	The patient will undergo lung function tests, and the diffusing capacity for carbon monoxide (DLCO) will be recorded.	12 weeks after surgery
Secondary	Percentage change in SGRQ score relative to baseline	The patient will receive a St.Georges respiratory questionnaire (SGRQ) questionnaire survey.	12 weeks after surgery
Secondary	Percentage change in mMRC grade relative to baseline	The patient will receive a modified Medical Research Council (mMRC) questionnaire.	12 weeks after surgery
Secondary	Percentage change in 6MWD relative to baseline	The patient will undergo 6-minute walk test, and 6-minute walk distance (6MWD) will be recored.	12 weeks after surgery
Secondary	the incidence of surgical-related adverse events	The surgical-related adverse events refers to pneumothorax, valve displacement or shedding, granuloma formation and other surgical-related adverse events.	12 weeks after surgery