Plain English Summary
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
Study website
Contact information
Type
Scientific
Contact name
Ms Sara Buttery
ORCID ID
Contact details
Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom
+44 (0)207 351 8029
s.buttery@rbht.nhs.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
30523
Study information
Scientific title
The CELEB trial: Comparative Effectiveness of Lung volume reduction surgery for Emphysema and Bronchoscopic lung volume reduction with valve placement
Acronym
CELEB
Study hypothesis
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
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
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Overall study end date
30/09/2020
Reason abandoned (if study stopped)
Eligibility
Participant 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
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
Participant 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
Recruitment start date
01/06/2016
Recruitment end date
01/06/2019
Locations
Countries of recruitment
England, Scotland, United Kingdom
Study participating centre
Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom
Study participating centre
Glenfield Hospital
University Hospitals Leicester
LE3 9QP
United Kingdom
Study participating centre
St Bartholomew’s Hospital
Barts Health NHS Foundation Trust
EC1A 7BE
United Kingdom
Study participating centre
Northern General Hospital
Sheffield
S5 7AU
United Kingdom
Study participating centre
Golden Jubilee National Hospital
Glasgow
G81 4DY
United Kingdom
Sponsor information
Organisation
Royal Brompton and Harefield NHS Foundation Trust
Sponsor details
Fulham Road
London
SW3 6NP
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research
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
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
30/09/2021
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Data sharing statement to be made available at a later date
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 |