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

• Register: ISRCTN
• Last refreshed on: 24 May 2021
• Main ID: ISRCTN19352730
• Date of registration: 05/10/2015
• Prospective Registration: No
• Primary sponsor: Portsmouth Hospitals NHS Trust
• Public title: Role of vinegar in identifying abnormal cells in Barrett’s oesophagus
• 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
• Date of first enrolment: 01/05/2015
• Target sample size: 200
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN19352730
• Study type: Interventional
• Study design: Feasibility study, including a multicentre randomised crossover diagnostic study and qualitative interviews (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Clive Stokes

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: Cancer, Gastroenterology; Subtopic: Upper Gastro-Intestinal Cancer, Gastroenterology; Disease: Oesophagus, All Gastroenterology
Digestive System
Barrett oesophagus

Intervention(s)

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.

Primary Outcome(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

Secondary Outcome(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

Secondary ID(s)

19276

Source(s) of Monetary Support

NIHR Central Commissioning Facility; Grant Codes: PB-PG-1013-32045

Ethics review

Status:
Approval date:
Contact:

15/SC/0085

Results

• Results available: Yes
• Date Completed: 01/12/2017