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. 2017 Feb 23;2017(2):CD012158. doi: 10.1002/14651858.CD012158.pub2

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:
  • Health‐related quality of life is measured using the COPD assessment test score (CAT)

  • Physical activity level

  • Change in residual volume (RV)

  • Fat‐free mass

Starting date April 2016
Contact information Dr Nick Hopkinson
Notes ISRCTN19684749