CELEB: Lung volume reduction in COPD - surgery vs endobronchial valves

ISRCTN	ISRCTN19684749
DOI	https://doi.org/10.1186/ISRCTN19684749
Secondary identifying numbers	30523

Submission date: 23/05/2016
Registration date: 23/05/2016
Last edited: 03/05/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Chronic obstructive pulmonary disease (COPD) is the collective name for a group of diseases which affect the lungs. One of the diseases is emphysema, a lung condition in which the tiny air sacs (alveoli) in the lungs become damaged over time. In emphysema, the alveoli become overfilled with air, causing the walls to weaken and eventually burst, creating one larger air space instead of many small ones. This means that the sufferer is unable to breathe out fully, leading to breathlessness which becomes progressively worse. Lung volume reduction surgery (LVRS) is an operation in which the worst affected part of the lung is removed, making more space for the remaining healthier lung to function. There is good evidence that in properly selected individuals this can improve breathlessness and increase life expectancy. It is a major operation and does carry a risk of complications however. A more recent approach is to use a fibreoptic camera (bronchoscope) to place valves into the airways of the lung. These stop air from entering the worst-affected section of the lung causing it to collapse, leading to similar benefits of LVRS. The aim of this study is to compare the effectiveness of these two techniques in the treatment of patients with emphysema.

Who can participate?
Adults with a heterogeneous pattern of emphysema (isolated to certain areas of the lungs and to a varying extent between segments of the lungs)

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group undergo lung volume reduction surgery. Those in the second group have endobronchial valves placed into their airways using a bronchoscope while they are sedated. One year after the procedures, participants in both groups undergo a number of physical tests to find out if their lung function has improved as well as their overall quality of life.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
1. Royal Brompton Hospital (UK)
2. Glenfield Hospital (UK)
3. St Bartholomew’s Hospital (UK)
4. Northern General Hospital (UK)
5. Golden Jubilee National Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2016 to September 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Sara Buttery
s.buttery@rbht.nhs.uk

Contact information

Ms Sara Buttery
Scientific

Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom

Phone	+44 (0)207 351 8029
Email	s.buttery@rbht.nhs.uk

Study information

Study design	Interventional; Design type: Treatment, Device, Surgery
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The CELEB trial: Comparative Effectiveness of Lung volume reduction surgery for Emphysema and Bronchoscopic lung volume reduction with valve placement
Study acronym	CELEB
Study objectives	The aim of this study is to evaluate the relative effectiveness and value of two options currently available for the treatment of COPD patients with a heterogeneous pattern of emphysema. These are lung volume reduction surgery (LVRS) and the bronchoscopic placement of endobronchial valves (BLVR).
Ethics approval(s)	London - Fulham Research Ethics Committee, 18/02/2016, ref: 16/LO/0286
Health condition(s) or problem(s) studied	Emphysema
Intervention	Patients will be randomised to either unilateral video assisted thoracoscopic (VATS) lung volume reduction surgery (LVRS) or endobronchial valves (BLVR) placed to achieve lobar occlusion.
Intervention type	Device
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	Change in iBODE score (a composite of BMI, FEV1, MRC dyspnoea score and shuttle walk test distance) one year post procedure.
Secondary outcome measures	1. Health related quality of life is measured using the COPD assessment test score (CAT) 2. Physical activity level 3. Change in residual volume (RV) 4. Fat free mass
Overall study start date	01/04/2016
Completion date	30/09/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 76; UK Sample Size: 76
Total final enrolment	88
Key inclusion criteria	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 3 or more 6. CT scan assessed at MDT to have intact interlobar fissures (>90%) and heterogeneous emphysema 7. Provision of informed consent to participate
Key exclusion criteria	1. Smoking within 3 months 2. CT scan shows interlobar fissures are not intact 3. Major comorbidity limiting survival 4. Significant pulmonary fibrosis 5. FEV1 and TLco <20% 6. PaO2 < 7.0kPa 7. PaO2 > 7kPa 8. Presence of interlobar collateral ventilation assessed by Chartis system
Date of first enrolment	01/06/2016
Date of final enrolment	01/06/2019

Locations

Countries of recruitment

England
Scotland
United Kingdom

Study participating centres

Royal Brompton Hospital

Fulham Road
London
SW3 6NP
United Kingdom

Glenfield Hospital

University Hospitals Leicester
LE3 9QP
United Kingdom

St Bartholomew’s Hospital

Barts Health NHS Foundation Trust
EC1A 7BE
United Kingdom

Northern General Hospital

Sheffield
S5 7AU
United Kingdom

Golden Jubilee National Hospital

Glasgow
G81 4DY
United Kingdom

Sponsor information

Royal Brompton and Harefield NHS Foundation Trust
Hospital/treatment centre

Fulham Road
London
SW3 6NP
England
United Kingdom

"ROR"	https://ror.org/02218z997

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	30/09/2021
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	17/10/2018	30/10/2019	Yes	No
Results article		27/04/2023	03/05/2023	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

03/05/2023: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
08/04/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/03/2020 to 30/09/2020.
2. The intention to publish date was added.
30/10/2019: Publication reference added.
02/04/2019: The condition has been changed from "Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Other diseases of the respiratory system" to "Emphysema" following a request from the NIHR.
12/06/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2018 to 01/06/2019.
2. The overall trial end date was changed from 31/03/2019 to 31/03/2020.
3. Northern General Hospital and Golden Jubilee National Hospital were added as trial participating centres.
15/11/2017: Contact details updated.
18/10/2017: New trial participating centres added.