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

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.

Conditions

• Barrett Esophagus

Interventions

DRUG

Acetic Acid

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

PROCEDURE

Non targeted quadrantic biopsies

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

Sponsors & Collaborators

• University Hospitals, Leicester

  collaborator OTHER

• University of Portsmouth

  collaborator OTHER

• Brighton and Sussex University Hospitals NHS Trust

  collaborator OTHER

• Western Sussex Hospitals NHS Trust

  collaborator OTHER

• Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• Gloucestershire Hospitals NHS Foundation Trust

  collaborator OTHER

• Portsmouth Hospitals NHS Trust

  lead OTHER_GOV

Principal Investigators

• Pradeep Bhandari, MBBS, MD · Portsmouth Hospitals NHS Trust

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-10

Primary Completion

2017-01-31

Completion

2018-02-28

Countries

• United Kingdom

Study Locations