The 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
File(s)e021368.full.pdf (508.83 KB)
Published version
Author(s)
Type
Journal Article
Abstract
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 (ISRCTN19684749), 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, lung function, breathlessness and exercise capacity.
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.
Methods and Analysis: We describe the protocol of the CELEB study (ISRCTN19684749), 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, lung function, breathlessness and exercise capacity.
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.
Date Issued
2018-10-17
Date Acceptance
2018-08-07
Citation
BMJ Open, 2018, 8
ISSN
2044-6055
Publisher
BMJ Journals
Journal / Book Title
BMJ Open
Volume
8
Copyright Statement
© 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/.
Sponsor
National Institute for Health Research
National Institute for Health Research
British Lung Foundation
Grant Number
PB-PG-1014-35051
UD99999959
BLF-PLMNX15-1
Subjects
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
ENDOBRONCHIAL VALVES
HETEROGENEOUS EMPHYSEMA
PHYSICAL-ACTIVITY
COPD
EXERCISE
OUTCOMES
COPD
emphysema
lung volume reduction
thoracic surgery
Publication Status
Published
Article Number
ARTN e021368
Date Publish Online
2018-10-17