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

NCT02407392 | Completed DMC

• 1 other identifier: PHT/2014/73
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (6)

• Participant acceptability of trial design

  18 months

• Comparison of dysplasia rates as assessed by the number of biopsies in each endoscopy required to detect dysplasia

  18 months

• Feasibility of training in Acetic Acid technique

  18 months

• Clinician's acceptability of using Acetic Acid technique

  18 months

• Facilitators and barriers to recruitment

  18 months

Study Arms (2)

Non targeted quadrantic biopsies

ACTIVE COMPARATOR

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

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.

Drug: Acetic Acid

Interventions

Acetic Acid DRUG

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

Acetic Acid targeted biopsies

Non targeted quadrantic biopsies PROCEDURE

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

Non targeted quadrantic biopsies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• University Hospitals, Leicester: collaborator
• University of Portsmouth: collaborator
• Brighton and Sussex University Hospitals NHS Trust: collaborator
• Western Sussex Hospitals NHS Trust: collaborator
• Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust: collaborator
• Gloucestershire Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Pradeep Bhandari, MBBS, MD

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: April 3, 2015
• Study Start: July 10, 2015
• Primary Completion: January 31, 2017
• Study Completion: February 1, 2018
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

GB (1)