Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Mr Clive Stokes
ORCID ID
Contact details
Gloucester Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Type
Scientific
Additional contact
Dr Gaius Longcroft-Wheaton
ORCID ID
Contact details
Portsmouth Hospitals NHS Trust
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
19276
Study information
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
Acronym
ABBA
Study hypothesis
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
15/SC/0085
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
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/02/2015
Overall trial end date
01/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 200; UK Sample Size: 200
Participant 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
Recruitment start date
01/05/2015
Recruitment end date
01/11/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Gloucestershire Royal Hospital
GL1 3NN
United Kingdom
Trial participating centre
Portsmouth Hospitals NHS Trust
PO6 3LY
United Kingdom
Trial participating centre
Leicester Royal Infirmary
LE1 5WW
United Kingdom
Trial participating centre
Brighton and Sussex University Hospitals
BN2 5BE
United Kingdom
Trial participating centre
The Royal Bournemouth and Christchurch Hospitals
BH7 7DW
United Kingdom
Trial participating centre
Western Sussex Hospitals
BN11 2DH
United Kingdom
Trial participating centre
University of Portsmouth
PO1 2FR
United Kingdom
Funders
Funder type
Government
Funder name
NIHR Central Commissioning Facility; Grant Codes: PB-PG-1013-32045
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list