Role of vinegar in identifying abnormal cells in Barrett’s oesophagus
| ISRCTN | ISRCTN19352730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19352730 |
| Secondary identifying numbers | 19276 |
- Submission date
- 22/07/2015
- Registration date
- 05/10/2015
- Last edited
- 10/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Mr Clive Stokes
Scientific
Scientific
Gloucester Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Dr Gaius Longcroft-Wheaton
Scientific
Scientific
Portsmouth Hospitals NHS Trust
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
Study information
| Study design | Feasibility study, including a multicentre randomised crossover diagnostic study and qualitative interviews |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A feasibility study with a crossover design to assess the diagnostic accuracy of acetic acid targeted biopsies versus non targeted biopsies (current practice) for detection of dysplasia during Barrett’s surveillance: the ABBA study |
| Study acronym | ABBA |
| Study objectives | Is a trial to investigate the diagnostic accuracy of acetic acid chromoendoscopy in a Barrett’s surveillance population feasible and acceptable to patients and clinicians? More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=19276 |
| Ethics approval(s) | 15/SC/0085 |
| Health condition(s) or problem(s) studied | Topic: Cancer, Gastroenterology; Subtopic: Upper Gastro-Intestinal Cancer, Gastroenterology; Disease: Oesophagus, All Gastroenterology |
| Intervention | Participants will have two gastroscopies 4-10 weeks apart – one using mapping biopsies (current practice) and one using acetic acid. We will monitor how many agree to participate and reasons for withdrawal from the study. Numbers of precancerous areas detected by each method will inform how many patients we need for a larger study to test which method is best. We will explore participants’ and doctors’ views about acceptability of the new technique and how to improve study procedures using telephone interviews. |
| Intervention type | Other |
| Primary outcome measure | 1. To determine the feasibility of recruiting 200 Barrett's surveillance patients in 18 months 2. To assess participant acceptability of the study design through quantitative measures related to study procedures and in-depth qualitative feedback 3. To identify the degree of difference in dysplasia (pre-cancerous changes) detection rates between acetic acid gastroscopy (targeted biopsies) and standard gastroscopic practice (non-targeted mapping biopsies) to inform the power calculation for a definitive study 4. Feasibility of training and implementation of acetic acid guided dysplasia detection technique 5. To explore the acceptability to clinicians and patients of the concept of using a targeted biopsy technique for surveillance instead of non-targeted, mapping biopsies 6. To identify potential facilitators and barriers to recruitment and retention for the definitive trial 7. To describe adverse events for the two methods |
| Secondary outcome measures | 1. To determine the feasibility of recruiting 200 Barrett's surveillance patients in 18 months 2. To assess participant acceptability of the study design through quantitative measures related to study procedures and in-depth qualitative feedback 3. To identify the degree of difference in dysplasia (pre-cancerous changes) detection rates between acetic acid gastroscopy (targeted biopsies) and standard gastroscopic practice (non-targeted mapping biopsies) to inform the power calculation for a definitive study 4. Feasibility of training and implementation of acetic acid guided dysplasia detection technique 5. To explore the acceptability to clinicians and patients of the concept of using a targeted biopsy technique for surveillance instead of non-targeted, mapping biopsies 6. To identify potential facilitators and barriers to recruitment and retention for the definitive trial 7. To describe adverse events for the two methods |
| Overall study start date | 01/02/2015 |
| Completion date | 01/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 200; UK Sample Size: 200 |
| Total final enrolment | 200 |
| Key inclusion criteria | 1. Aged 18 years or above 2. Biopsy proven Barrett’s metaplasia 3. At least 2cm of Barrett’s metaplasia (C0 M2) 4. Willing and able to give informed consent Target Gender: Male & Female ; Lower Age Limit 18 years |
| Key exclusion criteria | 1. Less than 2cm (C0 M2) of Barrett’s metaplasia 2. Significant oesophagitis 3. Known or prior oesophageal cancer 4. Known or prior oesophageal dysplasia (indefinite for dysplasia CAN be included) 5. Previous endoscopic therapy 6. Known allergy to acetic acid 7. Previous inclusion in the study |
| Date of first enrolment | 01/05/2015 |
| Date of final enrolment | 01/11/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Gloucestershire Royal Hospital
GL1 3NN
United Kingdom
United Kingdom
Portsmouth Hospitals NHS Trust
PO6 3LY
United Kingdom
United Kingdom
Leicester Royal Infirmary
LE1 5WW
United Kingdom
United Kingdom
Brighton and Sussex University Hospitals
BN2 5BE
United Kingdom
United Kingdom
The Royal Bournemouth and Christchurch Hospitals
BH7 7DW
United Kingdom
United Kingdom
Western Sussex Hospitals
BN11 2DH
United Kingdom
United Kingdom
University of Portsmouth
PO1 2FR
United Kingdom
United Kingdom
Sponsor information
Portsmouth Hospitals NHS Trust
Hospital/treatment centre
Hospital/treatment centre
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
England
United Kingdom
"ROR" |
https://ror.org/009fk3b63 |
|---|
Funders
Funder type
Government
NIHR Central Commissioning Facility; Grant Codes: PB-PG-1013-32045
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/01/2020 | 10/05/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/05/2021: Publication reference and total final enrolment added.
21/04/2016: Cancer Help UK lay summary link added.
