Barrett EsophagusABBANCT02407392
"Using Dilute Vinegar to Find Changes in Cells During Endoscopy for Patients With Barrett's Oesophagus" (The ABBA Study)
A study testing Acetic Acid and Non targeted quadrantic biopsies in people with Barrett Esophagus, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Problem statement Barrett's oesophagus is a pre-cancerous condition affecting 375,000 people in the U.K. There is a 0.5-3% yearly risk of progressing to oesophageal cancer, from which only 5% of patients will survive for 5 years after diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Acetic Acid and Non targeted quadrantic biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2015to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or above
- Biopsy proven Barrett's metaplasia
- At least 2cm of Barrett's metaplasia (C0 M2)
- Willing and able to give informed consent
Who cannot join
- Less than 2cm (C0 M2) of Barrett's metaplasia
- Significant oesophagitis
- Known or prior oesophageal cancer
- Known or prior oesophageal dysplasia (indefinite for dysplasia CAN be included)
- Previous endoscopic therapy
- Known allergy to acetic acid
- Previous inclusion in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acetic Acid Guided Biopsies in Barrett's Surveillance for Neoplasia Detection Versus Non-targeted Biopsies (Seattle Protocol): A Feasibility Study for a Randomised Tandem Endoscopy Trial. The ABBA Study.
Problem statement Barrett's oesophagus is a pre-cancerous condition affecting 375,000 people in the U.K. There is a 0.5-3% yearly risk of progressing to oesophageal cancer, from which only 5% of patients will survive for 5 years after diagnosis. Diagnosing the disease at the stage of dysplasia (pre-cancerous) and early cancer improves survival. This has led to the current surveillance strategy of gastroscopy with non-targeted mapping biopsies taken from the Barrett's oesophagus every two years. The large number of biopsies required is time consuming and expensive, yet dysplasia and cancerous tissue is still missed due to the non-targeted biopsy sampling strategy. Acetic acid has been used effectively in the early detection of cervical dysplasia and cancer, and has also been used with success in a high risk Barrett's population (patients with suspected dysplasia or previously treated dysplasia), but not been studied in the lower risk Barrett's surveillance population. A diagnostic study of non-targeted mapping biopsies (current practice) versus targeted biopsies (acetic acid) in a surveillance population is needed before widespread adoption of this technique is possible.
Read the detailed description
This is a feasibility study to enable powering of a larger study. The investigators would assume a disease detection of 4.5% with acetic acid chromoendoscopy and 1.5% with protocol driven mapping biopsies. However, these assumptions are largely driven from a single centre cohort study and as such need clarification before they could be used for the purposes of powering a study. Based on the historical cohort studies and wide consultation within the British Society of Gastroenterology research committee and consultation with experts in the field, it is estimated that 200 patients would be reasonable for recruitment to enable the reproducibility and generalisability of this data to be established. The purpose of this study is not to produce statistically significant data in itself but to establish likely event rates and effect size to inform the power calculation for the definitive study.
- Conditions
- Barrett Esophagus
- Being tested
- Acetic Acid, Non targeted quadrantic biopsies
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetic AcidDrug
During endoscopy Acetic acid will be sprayed onto Barrett's oesophagus and targeted biopsies of taken.
Non targeted quadrantic biopsiesProcedure or surgery
During endoscopy patients will undergo current standard quadrantic Seattle protocol biopsies of Barrett's oesophagus
| Study group | Role | What they receive |
|---|---|---|
| Non targeted quadrantic biopsies | Active comparator | Patients undergo current gold standard Barrett's surveillance with quadrantic Seattle protocol biopsies Receives: Procedure: Non targeted quadrantic biopsies |
| Acetic Acid targeted biopsies | Experimental | Patients undergo dye spray gastroscopy with Acetic Acid and targeted biopsies for areas of dysplasia. Receives: Drug: Acetic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by the ratio of patients approached to recruited, percentage of patients who complete both endoscopies
To determine the feasibility of recruiting 200 Barrett's surveillance patients in 18 months. Ratio of patients approached to recruited, percentage of patients who complete both endoscopies.
Measured: 18 months
Secondary outcomes (6)
Participant acceptability of trial design
To assess participant acceptability of the study design through quantitative measures related to study procedures and in-depth qualitative feedback. Qualitative feedback through semi-structured telephone interviews. Patients will be asked how acceptable they found having two endoscopies and whether they would be willing to undergo a study of similar design. This will measured by responses based on a telephone interview questionnaire.
Measured: 18 months
Comparison of dysplasia rates as assessed by the number of biopsies in each endoscopy required to detect dysplasia
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. Number of biopsies in each endoscopy required to detect dysplasia.
Measured: 18 months
Feasibility of training in Acetic Acid technique
Feasibility of training and implementation of acetic acid guided dysplasia detection technique. Online training module with pre and post training examination. Seminar based training day with further examination thereafter and correlation of scores following the above methods. The endoscopists will be tested on a validated video library pre and post training. A further test will be performed following 3-6 months to assess for drop off in ability. Percentage of correct answers will be calculated for each test
Measured: 18 months
Clinician's acceptability of using Acetic Acid technique
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. Semi-structured qualitative interview to explore clinician's attitude to the use of acetic acid following training and implementation of the study. Clinician's will be asked via a telephone interview on a scale of how confident they would be to use acetic acid alone in the surveillance of Barrett's without performing non-targeted biopsies. Clinical's attitudes will be assessed pre and post training as well as at the end of the study.
Measured: 18 months
Facilitators and barriers to recruitment
To identify potential facilitators and barriers to recruitment and retention for the definitive trial. Qualitative patient interview for both those enrolled in the study and those who have declined to identify themes that may assist recruitment into a larger study. This will be measured by means of a telephone questionnaire.
Measured: 18 months
Number of adverse events
Monitoring of adverse outcomes to describe adverse events for the two methods. Number of adverse events recorded in total.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study start10 Jul 2015
- Primary completion31 Jan 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University Hospitals, Leicester, University of Portsmouth, Brighton and Sussex University Hospitals NHS Trust, Western Sussex Hospitals NHS Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Gloucestershire Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Pradeep Bhandari, MBBS, MD, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407392
- Sponsor's protocol ID
- PHT/2014/73
- Acronym
- ABBA
- Status last verified
- Jul 2024
- First submitted
- 27 Jan 2015
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetic Acid Guided Biopsies in Barrett's Surveillance for Neoplasia Detection Versus Non-targeted Biopsies (Seattle Protocol): A Feasibility Study for a Randomised Tandem Endoscopy Trial. The ABBA Study.
- ClinicalTrials.gov ID
- NCT02407392
- Acronym / sponsor ID
- ABBA / PHT/2014/73
- Conditions
- Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- University Hospitals, Leicester, University of Portsmouth, Brighton and Sussex University Hospitals NHS Trust, Western Sussex Hospitals NHS Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Gloucestershire Hospitals NHS Foundation Trust
- Study start
- 10 Jul 2015 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Problem statement Barrett's oesophagus is a pre-cancerous condition affecting 375,000 people in the U.K. There is a 0.5-3% yearly risk of progressing to oesophageal cancer, from which only 5% of patients will survive for 5 years after diagnosis. Diagnosing the disease at the stage of dysplasia (pre-cancerous) and early cancer improves survival. This has led to the current surveillance strategy of gastroscopy with non-targeted mapping biopsies taken from the Barrett's oesophagus every two years. The large number of biopsies required is time consuming and expensive, yet dysplasia and cancerous tissue is still missed due to the non-targeted biopsy sampling strategy. Acetic acid has been used effectively in the early detection of cervical dysplasia and cancer, and has also been used with success in a high risk Barrett's population (patients with suspected dysplasia or previously treated dysplasia), but not been studied in the lower risk Barrett's surveillance population. A diagnostic study of non-targeted mapping biopsies (current practice) versus targeted biopsies (acetic acid) in a surveillance population is needed before widespread adoption of this technique is possible.
Detailed description
This is a feasibility study to enable powering of a larger study. The investigators would assume a disease detection of 4.5% with acetic acid chromoendoscopy and 1.5% with protocol driven mapping biopsies. However, these assumptions are largely driven from a single centre cohort study and as such need clarification before they could be used for the purposes of powering a study. Based on the historical cohort studies and wide consultation within the British Society of Gastroenterology research committee and consultation with experts in the field, it is estimated that 200 patients would be reasonable for recruitment to enable the reproducibility and generalisability of this data to be established. The purpose of this study is not to produce statistically significant data in itself but to establish likely event rates and effect size to inform the power calculation for the definitive study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non targeted quadrantic biopsies | Active comparator | Procedure: Non targeted quadrantic biopsiesPatients undergo current gold standard Barrett's surveillance with quadrantic Seattle protocol biopsies |
| Acetic Acid targeted biopsies | Experimental | Drug: Acetic AcidPatients undergo dye spray gastroscopy with Acetic Acid and targeted biopsies for areas of dysplasia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or above
- Biopsy proven Barrett's metaplasia
- At least 2cm of Barrett's metaplasia (C0 M2)
- Willing and able to give informed consent
Key exclusion criteria (7 listed)
- Less than 2cm (C0 M2) of Barrett's metaplasia
- Significant oesophagitis
- Known or prior oesophageal cancer
- Known or prior oesophageal dysplasia (indefinite for dysplasia CAN be included)
- Previous endoscopic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetic AcidDuring endoscopy Acetic acid will be sprayed onto Barrett's oesophagus and targeted biopsies of taken. | Drug | Acetic Acid targeted biopsies |
| Non targeted quadrantic biopsiesDuring endoscopy patients will undergo current standard quadrantic Seattle protocol biopsies of Barrett's oesophagus | Procedure or surgery | Non targeted quadrantic biopsies |
Primary outcome
Feasibility as assessed by the ratio of patients approached to recruited, percentage of patients who complete both endoscopies
Time frame: 18 months
To determine the feasibility of recruiting 200 Barrett's surveillance patients in 18 months. Ratio of patients approached to recruited, percentage of patients who complete both endoscopies.
6 secondary outcomes
Participant acceptability of trial design
Time frame: 18 months
Comparison of dysplasia rates as assessed by the number of biopsies in each endoscopy required to detect dysplasia
Time frame: 18 months
Feasibility of training in Acetic Acid technique
Time frame: 18 months
Clinician's acceptability of using Acetic Acid technique
Time frame: 18 months
Facilitators and barriers to recruitment
Time frame: 18 months
Number of adverse events
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pradeep Bhandari, MBBS, MD principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetic Acid and Non targeted quadrantic biopsies in people with Barrett Esophagus, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by the ratio of patients approached to recruited, percentage of patients who complete both endoscopies (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.