"Using Dilute Vinegar to Find Changes in Cells During Endoscopy for Patients With Barrett's Oesophagus" (The ABBA Study)

NCT ID: NCT02407392

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-10
• Study Completion Date: 2018-02-28

Brief 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. 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.

Conditions

Barrett Esophagus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Non targeted quadrantic biopsies

Patients undergo current gold standard Barrett's surveillance with quadrantic Seattle protocol biopsies

Group Type: ACTIVE_COMPARATOR

Non targeted quadrantic biopsies

Intervention Type: PROCEDURE

During endoscopy patients will undergo current standard quadrantic Seattle protocol biopsies of Barrett's oesophagus

Acetic Acid targeted biopsies

Patients undergo dye spray gastroscopy with Acetic Acid and targeted biopsies for areas of dysplasia.

Group Type: EXPERIMENTAL

Acetic Acid

Intervention Type: DRUG

During endoscopy Acetic acid will be sprayed onto Barrett's oesophagus and targeted biopsies of taken.

Interventions

Acetic Acid

During endoscopy Acetic acid will be sprayed onto Barrett's oesophagus and targeted biopsies of taken.

Intervention Type: DRUG

Non targeted quadrantic biopsies

During endoscopy patients will undergo current standard quadrantic Seattle protocol biopsies of Barrett's oesophagus

Intervention Type: PROCEDURE

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals, Leicester

OTHER

Sponsor Role: collaborator

University of Portsmouth

OTHER

Sponsor Role: collaborator

Brighton and Sussex University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Western Sussex Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

Gloucestershire Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pradeep Bhandari, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Portsmouth Hospitals NHS Trust

Locations

Queen Alexandra Hospital

Portsmouth, , United Kingdom

Countries

United Kingdom

Other Identifiers

PHT/2014/73

Identifier Type: -

Identifier Source: org_study_id