ISRCTN88972567
Active, not recruiting
未知
Barrett’s oESophagus Trial 4 (BEST4): A Prospective Cohort trial for the Surveillance of Barrett’s Oesophagus using a capsule sponge test and biomarker panel
Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge0 sites2,000 target enrollmentNovember 23, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- non-dysplastic Barrett's oesophagus
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge
- Enrollment
- 2000
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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
Outcomes
Primary Outcomes
Not specified
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