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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

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 t...

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Autores principales: Buttery, Sara, Kemp, Samuel V, Shah, Pallav L, Waller, David, Jordan, Simon, Lee, John T, Banya, Winston, Steiner, Michael C, Hopkinson, Nicholas S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6196851/
https://www.ncbi.nlm.nih.gov/pubmed/30337307
http://dx.doi.org/10.1136/bmjopen-2017-021368
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author Buttery, Sara
Kemp, Samuel V
Shah, Pallav L
Waller, David
Jordan, Simon
Lee, John T
Banya, Winston
Steiner, Michael C
Hopkinson, Nicholas S
author_facet Buttery, Sara
Kemp, Samuel V
Shah, Pallav L
Waller, David
Jordan, Simon
Lee, John T
Banya, Winston
Steiner, Michael C
Hopkinson, Nicholas S
author_sort Buttery, Sara
collection PubMed
description 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.
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spelling pubmed-61968512018-10-25 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 Buttery, Sara Kemp, Samuel V Shah, Pallav L Waller, David Jordan, Simon Lee, John T Banya, Winston Steiner, Michael C Hopkinson, Nicholas S BMJ Open Respiratory Medicine 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. BMJ Publishing Group 2018-10-17 /pmc/articles/PMC6196851/ /pubmed/30337307 http://dx.doi.org/10.1136/bmjopen-2017-021368 Text en © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Respiratory Medicine
Buttery, Sara
Kemp, Samuel V
Shah, Pallav L
Waller, David
Jordan, Simon
Lee, John T
Banya, Winston
Steiner, Michael C
Hopkinson, Nicholas S
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Respiratory Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6196851/
https://www.ncbi.nlm.nih.gov/pubmed/30337307
http://dx.doi.org/10.1136/bmjopen-2017-021368
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