Esophagus to Small Intestine

Gastroenterology. 2025;169(6):1233-1243.e8

Old O, Jankowski J, Attwood S, Stokes C, Kendall C, Rasdell C, Zimmermann A, Massa MS, Love S, Sanders S, Deidda M, Briggs A, Hapeshi J, Foy C, Moayyedi P, Barr H; BOSS Trial Team

Barrett’s oesophagus surveillance versus endoscopy at need study (BOSS): A randomized controlled trial


Background and aims: Barrett’s esophagus (BE) is a precursor lesion for esophageal adenocarcinoma (EAC). Surveillance endoscopy aims to detect early malignant progression; although widely practiced, it has not previously been tested in a randomized trial.
Methods: BOSS (Barrett’s Oesophagus Surveillance Versus Endoscopy at Need Study) was a randomized controlled trial at 109 centers in the United Kingdom. Patients with BE were randomized to 2-yearly surveillance endoscopy or “at-need” endoscopy, offered for symptoms only. 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 EAC, stage of EAC at diagnosis, frequency of endoscopy, and serious adverse events related to interventions.
Results: There were 3,453 patients recruited; 1,733 patients were randomized to surveillance and 1,719 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 the surveillance arm (333 deaths among 1,733 patients) and the at-need arm (356 deaths among 1,719 patients; hazard ratio [HR] = 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 EAC (40 vs. 31 patients had a diagnosis of EAC; HR = 1.32; 95% CI: 0.82–2.11; p = 0.254), or cancer stage at diagnosis. Eight surveillance patients (0.46%) and 7 at-need patients (0.41%) reported serious adverse events.

Conclusions: Surveillance did not improve overall survival or cancer-specific survival. At-need endoscopy may be a safe alternative for low-risk patients.

O. Old, Gloucestershire Hospitals, NHS Foundation Trust, Gloucester, UK, e-mail: oliver.old@nhs.net

DOI:  10.1053/j.gastro.2025.03.021

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