Evaluation of Bronchoscopic Biological Lung Volume Reduction Therapy in Pulmonary Emphysema Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Post-procedure lung volume reduction
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Emphysema determined by HRCT of the chest with:
- •.Persistent symptoms (i.e. a baseline Modified Medical Research Council dyspnea (MRC) score of >2 despite medical therapy).
- •FEV1 /FVC < 70% and FEV1 20%-50 % (Sever and very sever airflow limitation according to GOLD 2013).
- •Hyperinflation (total lung capacity (TLC) > 110% pred and residual volume/total lung capacity (RV/TLC) > 120% pred.
- •Patients not candidate for or had refused lung volume reduction surgery.
- •Age > 40 yrs.
Exclusion Criteria
- •Airflow limitation with FEV1 < 20%.
- •DLCO < 20%.
- •Current smoker.
- •Patients not candidate for FOB.
Arms & Interventions
Bronchoscopic Lung volume reduction using Autologous blood.
Injection of 30 ml autologous blood plus 3ml calcium chloride plus 3 ml tranexamic acid per segment via fiber-optic bronchoscope
Intervention: Bronchoscopic Lung volume reduction (Procedure)
Bronchoscopic Lung volume reduction using Fibrin glue
injection of 30 ml locally prepared fibrin glue per segment via triple lumen balloon catheter passing through fiberoptic bronchoscopy
Intervention: Bronchoscopic Lung volume reduction (Procedure)
Outcomes
Primary Outcomes
Post-procedure lung volume reduction
Time Frame: 12 week
Change from the baseline high-resolution computed tomography (HRCT) volumetry Change from the baseline Residual Volume/Total Lung Capacity from baseline.
Secondary Outcomes
- Post-procedure Improvement in dyspnea and exercise capacity(12 weeks)
Investigators
Mostafa Bakeer
Dr
Mansoura University