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The clinical utility of bronchoscopic methods for achieving lung volume reduction has been evaluated in patients with advanced emphysema because these procedures are uniformly safer than surgical volume reduction. These include one-way valves, or bronchial occlusive devices to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to improve expiratory flow, wire coils implants that compress the airway and thermal vapor ablation that causes an acute injury with subsequent fibrosis and reductions in volume.
Biologic lung volume reduction (BioLVR): it is a novel endobronchial approach, which uses a Biological agents aiming to reduce lung volume by blocking off the most emphysematous areas with a rapidly polymerizing sealant. The mechanism of action involves resorption atelectasis from airway occlusion, subsequent airspace inflammation, and then remodeling. This remodeling will lead to scarring that induces contraction of lung parenchyma and functional volume reduction can be expected within 6-8 weeks. Biological lung volume reduction occurs independent of the presence or absence of collateral ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchoscopic Lung volume reduction using Autologous blood. | Experimental | Injection of 30 ml autologous blood plus 3ml calcium chloride plus 3 ml tranexamic acid per segment via fiber-optic bronchoscope |
|
| Bronchoscopic Lung volume reduction using Fibrin glue | Active Comparator | injection of 30 ml locally prepared fibrin glue per segment via triple lumen balloon catheter passing through fiberoptic bronchoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchoscopic Lung volume reduction | Procedure | Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedure lung volume reduction | Change from the baseline high-resolution computed tomography (HRCT) volumetry Change from the baseline Residual Volume/Total Lung Capacity from baseline. | 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedure Improvement in dyspnea and exercise capacity | Changes from the baseline post-bronchodilator forced expiratory volume at one second (FEV1) and forced vital capacity (FVC), diffusing capacity of lung for carbon monoxide (DLCO), six-minute walk distance (6MWD),modified medical research council (MMRC) dyspnea score. | 12 weeks |
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Inclusion Criteria:
Emphysema determined by HRCT of the chest with:
Patients not candidate for or had refused lung volume reduction surgery.
Age > 40 yrs.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad Saad El-Morsi, Prof | Chest Medicine Department, Faculty of Medicine, Mansoura University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chest Medicine Department, Faculty Of Medicine, Mansoura University | Al Mansurah | Al-dakahliya | 35516 | Egypt |
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| ID | Term |
|---|---|
| D011656 | Pulmonary Emphysema |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011013 | Pneumonectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |