Condition category
Digestive System
Date applied
22/07/2015
Date assigned
05/10/2015
Last edited
21/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 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

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

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

Sponsor information

Organisation

Portsmouth Hospitals NHS Trust

Sponsor details

Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

21/04/2016: Cancer Help UK lay summary link added.