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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endobronchial valve group | Experimental | The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bronchoscopic lung volume reduction surgery using endobronchial valve | Procedure | The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in FEV1 relative to baseline | The patient will undergo lung function tests. | 12 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators | The patient will undergo lung function tests. | 12 weeks after surgery |
| Percentage change in RV relative to baseline | The patient will undergo lung function tests, and residual volume (RV) will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Hou, MD | Contact | 010-84205729 | hougangcmu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| 12 weeks after surgery |
| 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 |
| 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 |
| Percentage change in SGRQ score relative to baseline | The patient will receive a St.Georges respiratory questionnaire (SGRQ) questionnaire survey. | 12 weeks after surgery |
| Percentage change in mMRC grade relative to baseline | The patient will receive a modified Medical Research Council (mMRC) questionnaire. | 12 weeks after surgery |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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