Role of vinegar in identifying abnormal cells in Barrett’s oesophagus

ISRCTN ISRCTN19352730
DOI https://doi.org/10.1186/ISRCTN19352730
Protocol serial number 19276
Sponsor Portsmouth Hospitals NHS Trust
Funder NIHR Central Commissioning Facility; Grant Codes: PB-PG-1013-32045
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

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-using-vinegar-find-changes-cells-people-barretts-oesophagus-abba

Contact information

Mr Clive Stokes
Scientific

Gloucester Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Dr Gaius Longcroft-Wheaton
Scientific

Portsmouth Hospitals NHS Trust
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Study information

Primary study designInterventional
Study designFeasibility study, including a multicentre randomised crossover diagnostic study and qualitative interviews
Secondary study designRandomised cross over trial
Study type Participant information sheet
Scientific titleA 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 acronymABBA
Study objectivesIs 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) studiedTopic: Cancer, Gastroenterology; Subtopic: Upper Gastro-Intestinal Cancer, Gastroenterology; Disease: Oesophagus, All Gastroenterology
InterventionParticipants 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date01/12/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration200
Total final enrolment200
Key inclusion criteria1. 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 criteria1. 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 enrolment01/05/2015
Date of final enrolment01/11/2017

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centres

Gloucestershire Royal Hospital
GL1 3NN
United Kingdom
Portsmouth Hospitals NHS Trust
PO6 3LY
United Kingdom
Leicester Royal Infirmary
LE1 5WW
United Kingdom
Brighton and Sussex University Hospitals
BN2 5BE
United Kingdom
The Royal Bournemouth and Christchurch Hospitals
BH7 7DW
United Kingdom
Western Sussex Hospitals
BN11 2DH
United Kingdom
University of Portsmouth
PO1 2FR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

10/05/2021: Publication reference and total final enrolment added.
21/04/2016: Cancer Help UK lay summary link added.

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