Trial Information

Barrett's Oesophagus Two Yearly Surveillance Versus Endoscopy at Need: a Randomised Controlled Trial to Estimate Effectiveness and Cost-effectiveness Study (BOSS)

OBJECTIVES:

Primary

- To establish whether endoscopic surveillance every 2 years or endoscopy at need only is
superior in terms of overall survival and, if neither is superior, whether endoscopy at
need only is non-inferior to surveillance every 2 years in patients with Barrett
esophagus.

Secondary

- To estimate the cost-effectiveness of endoscopic surveillance every 2 years as compared
to endoscopy at need only.

- To establish whether there is a significant difference between endoscopic surveillance
every 2 years or endoscopy at need only in terms of the incidence of esophageal cancer,
gastric or esophageal cancer, or all cancers.

- To establish whether there is a significant difference between endoscopic surveillance
every 2 years or endoscopy at need only in terms of the time to diagnosis of esophageal
adenocarcinoma.

- To establish whether there is a significant difference between endoscopic surveillance
every 2 years or endoscopy at need only in terms of the stage of esophageal
adenocarcinoma at diagnosis using TNM staging.

- To establish whether there is a significant difference between endoscopic surveillance
every 2 years or endoscopy at need only in terms of morbidity and mortality related to
endoscopy, esophageal surgery, and other endoscopy-related interventions (e.g.,
ablation).

- To establish whether there is a significant difference between endoscopic surveillance
every 2 years or endoscopy at need only in terms of the frequency of endoscopy.

OUTLINE: This is a multicenter study. Patients are stratified according to age at diagnosis
(< 65 years vs ≥ 65 years), length of Barrett metaplasia segment including tongues (< 2 cm
vs ≥ 2 cm and ≤ 3 cm vs > 3 cm and ≤ 8 cm vs > 8 cm), and newly diagnosed disease (defined
as the date of endoscopy confirming Barrett metaplasia was within the past 4 months) (yes vs
no). Patients are randomized to 1 of 2 intervention arms.

- Arm I: Patients undergo surveillance endoscopy with quadrantic biopsies taken every 2
cm. Patients undergo endoscopy every 2 years for a total of 6 endoscopies over 10
years.

- Arm II: Patients undergo endoscopy as needed over 10 years. All patients may undergo
urgent endoscopy if they develop dysphagia, unexplained weight loss of > 7 lb,
iron-deficiency anemia, recurrent vomiting, or worsening upper gastrointestinal
symptoms.

All patients complete a questionnaire that includes a quality-of-life measure and questions
about medication at baseline, every 2 years, and following key events (e.g., diagnosis of
any cancer or high-grade dysplasia).