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Barrett's Oesophagus Surveillance versus endoscopy at need Study (BOSS) : protocol and analysis plan for a multicentre randomized controlled trial
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Old, Oliver, Moayyedi, Paul, Love, Sharon, Roberts, Corran, Hapeshi, Julie, Foy, Chris, Stokes, Clive, Briggs, Andrew H., Jankowski, Janusz A. Z. and Barr, Hugh (2015) Barrett's Oesophagus Surveillance versus endoscopy at need Study (BOSS) : protocol and analysis plan for a multicentre randomized controlled trial. Journal of Medical Screening, 22 (3). pp. 158-164. doi:10.1177/0969141315575052 ISSN 0969-1413.
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Official URL: http://dx.doi.org/10.1177/0969141315575052
Abstract
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 (3.2kg), iron deficiency anaemia, recurrent vomiting, or worsening upper gastrointestinal symptoms. Participants must have endoscopically and histologically confirmed BO, with circumferential BO ≥1cm 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.
Item Type: | Journal Article | ||||||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||||||
Journal or Publication Title: | Journal of Medical Screening | ||||||||||
Publisher: | Sage Publications Ltd. | ||||||||||
ISSN: | 0969-1413 | ||||||||||
Official Date: | September 2015 | ||||||||||
Dates: |
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Volume: | 22 | ||||||||||
Number: | 3 | ||||||||||
Page Range: | pp. 158-164 | ||||||||||
DOI: | 10.1177/0969141315575052 | ||||||||||
Status: | Peer Reviewed | ||||||||||
Publication Status: | Published | ||||||||||
Access rights to Published version: | Restricted or Subscription Access |
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