Barrett's Oesophagus Surveillance versus endoscopy at need Study (BOSS): a randomized controlled trial
Abstract
BACKGROUND AND AIMS
Barrett's esophagus (BE) is a precursor lesion for esophageal adenocarcinoma (EA). Surveillance endoscopy aims to detect early malignant progression: though widely practised it has not previously been tested in a randomized trial.
METHODS
BOSS was a randomized controlled trial at 109 centres in the UK. Patients with BE were randomized to two-yearly surveillance endoscopy or 'at need' endoscopy, offered only for symptoms. Follow up was a minimum of 10 years. The primary outcome was overall survival in the intention-to-treat population. Secondary outcomes included cancer-specific survival; time to diagnosis of EA; stage of EA at diagnosis; frequency of endoscopy and serious adverse events related to interventions.
RESULTS
3453 patients were recruited. 1733 patients were randomized to surveillance and 1719 to 'at need' endoscopy. Median follow up time was 12·8 years for the primary outcome. There was no evidence of a difference in overall survival between surveillance (333 deaths in 1733 patients) versus 'at need' arms (356 deaths in 1719 patients), hazard ratio 0·95 (95% CI 0·82-1·10), stratified log-rank p=0·503). There was no evidence of a difference for surveillance versus 'at need' endoscopy in cancer-specific survival (108 vs. 106 deaths from any cancer, HR 1·01 (95% CI 0·77-1·33), p=0·926), time to diagnosis of EA (40 vs. 31 patients had a diagnosis of EA, HR 1·32 (95% CI 0·82-2·11), p=0·254), or cancer stage at diagnosis. 8 (0·46%) surveillance…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 3,453 participants or records.
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