ISRCTN19684749.
Trial name or title | ISRCTN19684749: Comparative effectiveness of lung volume reduction surgery for emphysema and bronchoscopic lung volume reduction with valve placement |
Methods | Randomized parallel trial. Follow‐up: unknown. Estimated enrolment: 152 participants Sites: hospitals in UK |
Participants | Participants suffering from heterogeneous emphysema: 1. Adults (aged 18 or over) with COPD 2. FEV1 < 60% predicted 3. Significant hyperinflation (TLC > 100% predicted, RV > 170% predicted) 4. Ex‐smoker > 3 months 5. MRC dyspnoea score of 3 or more 6. CT scan assessed to have intact interlobar fissures (> 90%) and heterogeneous emphysema 7. Provision of informed consent to participate |
Interventions | Lung volume reduction surgery versus endobronchial valves: Participants will be randomized to either unilateral video assisted thoracoscopic (VATS) lung volume reduction surgery (LVRS) or endobronchial valves (BLVR) placed to achieve lobar occlusion. |
Outcomes |
Primary: Change in iBODE score (a composite of BMI, FEV1, MRC dyspnoea score and shuttle walk test distance) one year post‐procedure. Secondary:
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Starting date | April 2016 |
Contact information | Dr Nick Hopkinson |
Notes | ISRCTN19684749 |