- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02407392
"Using Dilute Vinegar to Find Changes in Cells During Endoscopy for Patients With Barrett's Oesophagus" (The ABBA Study) (ABBA)
March 31, 2016 updated by: Pradeep Bhandari, Portsmouth Hospitals NHS Trust
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fergus Chedgy, MBBS
- Phone Number: 02392286255
- Email: fergus.chedgy@porthosp.nhs.uk
Study Locations
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Portsmouth, United Kingdom, PO6 3LY
- Recruiting
- Queen Alexandra Hospital
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Contact:
- Fergus Chedgy, MBBS, MRCP
- Email: fergus.chedgy@porthosp.nhs.uk
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Non targeted quadrantic biopsies
Patients undergo current gold standard Barrett's surveillance with quadrantic Seattle protocol biopsies
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During endoscopy patients will undergo current standard quadrantic Seattle protocol biopsies of Barrett's oesophagus
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Experimental: Acetic Acid targeted biopsies
Patients undergo dye spray gastroscopy with Acetic Acid and targeted biopsies for areas of dysplasia.
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During endoscopy Acetic acid will be sprayed onto Barrett's oesophagus and targeted biopsies of taken.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility as assessed by the ratio of patients approached to recruited, percentage of patients who complete both endoscopies
Time Frame: 18 months
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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.
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18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant acceptability of trial design
Time Frame: 18 months
|
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.
|
18 months
|
Comparison of dysplasia rates as assessed by the number of biopsies in each endoscopy required to detect dysplasia
Time Frame: 18 months
|
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.
|
18 months
|
Feasibility of training in Acetic Acid technique
Time Frame: 18 months
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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
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18 months
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Clinician's acceptability of using Acetic Acid technique
Time Frame: 18 months
|
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.
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18 months
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Facilitators and barriers to recruitment
Time Frame: 18 months
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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.
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18 months
|
Number of adverse events
Time Frame: 18 months
|
Monitoring of adverse outcomes to describe adverse events for the two methods.
Number of adverse events recorded in total.
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pradeep Bhandari, MBBS, MD, Portsmouth Hospitals NHS Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Anticipated)
March 1, 2017
Study Completion (Anticipated)
September 1, 2017
Study Registration Dates
First Submitted
January 27, 2015
First Submitted That Met QC Criteria
March 30, 2015
First Posted (Estimate)
April 3, 2015
Study Record Updates
Last Update Posted (Estimate)
April 1, 2016
Last Update Submitted That Met QC Criteria
March 31, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Gastrointestinal Diseases
- Esophageal Diseases
- Precancerous Conditions
- Barrett Esophagus
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Anti-Bacterial Agents
- Adjuvants, Immunologic
- Anticarcinogenic Agents
- Acetic Acid
- Retinol acetate
Other Study ID Numbers
- PHT/2014/73
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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