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Patients with large bullae (large empty air sacs in the lung) may benefit from bullectomy (surgery to resect these bullae), however this is a major surgery with significant potential morbidity and long hospital stays. Many patients are not well enough to have this surgery, or may not wish to have it. A less invasive means of attempting to shrink the size of the bullae is to directly inject the patients' own blood into the bullae (we believe that this can lead to an inflammatory reaction leading to gradual scarring and volume loss). This can be performed bronchoscopically in a 20-30 minute procedure using conscious sedation (avoiding general anaesthesia).
The aim of this study is to assess the effects on lung function, quality of life measures, functional measures and CT measured lung volumes of bronchoscopic intrabullous blood instillation in patients with bullous emphysema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIABI arm | Experimental | Patients will undergo intrabullous autologous blood instillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchoscopic intrabullous autologous blood instillation | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Residual Volume (RV) following treatment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TLC 6 months following treatment | 6 months | |
| Change in RV/TLC ratio 6 months following treatment | 6 months | |
| Changes in FEV1 and FVC 6 months following treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zaid Zoumot, MBBS MRCP MSc | Contact | +442073518029 | zzoumot@doctors.org.uk |
| Name | Affiliation | Role |
|---|---|---|
| Pallav L Shah, MD FRCP | Royal Brompton and Chelsea and Westminster Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kings Mill Hospital, Sherwood Forest Hospitals NHS Trust | Recruiting | Mansfield | Nottinghamshire, | N | United Kingdom |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001768 | Blister |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 6 months |
| Change in the intrathoracic gas volume 6 months following treatment | 6 months |
| Change in DLCOc 6 months following treatment | 6 months |
| Change in the SGRQ score 6 months following treatment | 6 months |
| Change in the mMRC score 6 months following treatment | 6 months |
| Change in the 6MWD 6 months following treatment | 6 months |
| Change in CT measured lung volumes 6 months following treatment | 6 months |
| Adverse events | 6 monhts |
| The Royal Brompton and Harefield NHS Trust | Recruiting | London | SW3 6NP | United Kingdom |
|
| Chelsea and Westminster Hospital NHS Foundation trust | Recruiting | London | SW9 0HN | United Kingdom |
|
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |