BEST4 Surveillance Trial: Using the capsule sponge test in surveillance of Barrett’s Oesophagus.

Not Applicable

• Conditions: non-dysplastic Barrett's oesophagus; Digestive System

• Registration Number: ISRCTN88972567
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-23
• Last Update Posted: 18 March 2024
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Cohort1
Have participated in the BEST4 Screening study where;TFF3 positive on capsule sponge and as part of confirmatory endoscopy at participating secondary care site were diagnosed with NDBO defined as endoscopic evidence of BO at least 2cm (Prague C> = 0 and M> = 2) and intestinal metaplasia with no dysplasia in biopsies taken according to the Seattle protocol.

OR

Cohort 2
1. Be aged > = 18years
2. Have a known diagnosis of NDBO, defined as endoscopic evidence of BO at least 2 cm (Prague C> = 0 and M> = 2) and intestinal metaplasia with no dysplasia in biopsies taken at the previous endoscopy
3. Be presenting for routine endoscopic surveillance at a participating secondary care site.

Exclusion Criteria

1. Recorded high grade dysplasia on last endoscopy (note, low grade dysplasia or indefinite for dysplasia previous to last endoscopy is not an exclusion)
2. Recorded diagnosis of an oro-pharynx, oesophageal or gastro-oesophageal tumour, or symptoms of dysphagia (food sticking)
3. Received prior endoscopic (photodynamic therapy, endoscopic resection or radiofrequency ablation) or surgical intervention to the oesophagus (note, this does not include previous fundoplication treatment)
4. Recorded oesophageal varices, cirrhosis of the liver (including compensated Child A cirrhosis)
5. Unable to follow device anti-coagulation medication guidance
6. Difficulty in swallowing due to a known cerebrovascular accident or neurological disorder
7. Known pregnancy
8. Lack capacity to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified