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

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

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.

Conditions3

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