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CELEB trial: Comparative Effectiveness of Lung volume reduction surgery for Emphysema and Bronchoscopic lung volume reduction with valve placement: a protocol for a randomised controlled trial.

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posted on 2019-09-24, 16:41 authored by S Buttery, SV Kemp, PL Shah, D Waller, S Jordan, JT Lee, W Banya, MC Steiner, NS Hopkinson
INTRODUCTION: Although lung volume reduction surgery and bronchoscopic lung volume reduction with endobronchial valves have both been shown to improve lung function, exercise capacity and quality of life in appropriately selected patients with emphysema, there are no direct comparison data between the two procedures to inform clinical decision-making. METHODS AND ANALYSIS: We describe the protocol of the CELEB study, a randomised controlled trial which will compare outcomes at 1 year between the two procedures, using a composite disease severity measure, the iBODE score, which includes body mass index, airflow obstruction, dyspnoeaand exercise capacity (incremental shuttle walk test). ETHICS AND DISSEMINATION: Ethical approval to conduct the study has been obtained from the Fulham Research Ethics Committee, London (16/LO/0286). The outcome of this trial will provide information to guide treatment choices in this population and will be presented at national and international meetings and published in peer-reviewed journals. We will also disseminate the main results to all participants in a letter. TRIAL REGISTRATION NUMBER: ISRCTN19684749; Pre-results.

Funding

The study is funded by a grant to Royal Brompton and Harefield NHS Foundation Trust, from the NIHR, through the Research for Patient Benefit scheme (PB-PG-1014-35051). Imperial College, London will support the reporting of this manuscript. Trial sponsor representative: Patrik Pettersson, Royal Brompton and Harefield NHS Foundation Trust (RB&HFT), Royal Brompton Hospital.

History

Citation

BMJ Open 2018;8:e021368

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Infection, Immunity and Inflammation

Version

  • VoR (Version of Record)

Published in

BMJ Open 2018;8:e021368

Publisher

BMJ Publishing Group

eissn

2044-6055

Acceptance date

2018-08-07

Copyright date

2018

Available date

2019-09-24

Publisher version

https://bmjopen.bmj.com/content/8/10/e021368

Notes

Prepublication history for this paper is available online. To view these files please visit the journal online (http://dx.doi.org/10.1136/bmjopen-2017-021368).

Language

en

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