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OBJECTIVES: The absolute annual risk of patients with Barrett's oesophagus (BO) developing oesophageal adenocarcinoma (OAC) is ≤ 0.5%. Screening BO patients for malignant progression using endoscopic surveillance is widely practised. To assess the efficacy and cost-effectiveness of this, we developed a protocol for a randomized controlled trial of surveillance versus 'at need' endoscopy. METHODS: In a multicentre trial, 3400 BO patients randomized to either 2-yearly endoscopic surveillance or 'at need' endoscopy will be followed up for 10 years. Urgent endoscopy will be offered to all patients who develop symptoms of dysphagia, unexplained weight loss > 7lb (3.2 kg), iron deficiency anaemia, recurrent vomiting, or worsening upper gastrointestinal symptoms. Participants must have endoscopically and histologically confirmed BO, with circumferential BO ≥ 1 cm or maximal tongue/island length ≥ 2 cm. Candidates with existing oesophageal high-grade dysplasia or cancer, or previous upper gastrointestinal cancer will be excluded. Primary outcome will be overall survival. Secondary outcomes will be cost effectiveness (cost per life year saved and quality adjusted life years); cancer-specific survival; time to OAC diagnosis and stage at diagnosis; morbidity and mortality related to any interventions; and frequency of endoscopy. CONCLUSIONS: This randomized trial will provide data to evaluate the efficacy and cost-effectiveness of screening BO patients for OAC.

Original publication

DOI

10.1177/0969141315575052

Type

Journal article

Journal

J Med Screen

Publication Date

09/2015

Volume

22

Pages

158 - 164

Keywords

Barrett's oesophagus, Endoscopy, Gastro-oesophageal reflux disease, Oesophageal adenocarcinoma, Randomized controlled trial, Surveillance, Adenocarcinoma, Adult, Aged, Barrett Esophagus, Cost-Benefit Analysis, Disease Progression, Early Detection of Cancer, Endoscopy, Esophageal Neoplasms, Female, Follow-Up Studies, Humans, Male, Middle Aged, Research Design, Risk, Treatment Outcome, Young Adult