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

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Portsmouth Hospitals NHS Trust
• Collaborators: Brighton and Sussex University Hospitals NHS Trust; Gloucestershire Hospitals NHS Foundation Trust; Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust; University Hospitals, Leicester; University of Portsmouth; Western Sussex Hospitals NHS Trust
• Treatments: Acetic Acid; Retinol acetate

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