NCT00987857

Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,400 (actual)
• Sponsor: Gloucestershire Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment. It is not yet known whether endoscopy every 2 years is more effective than endoscopy only as needed in finding esophageal cancer in patients with Barrett esophagus. PURPOSE: This randomized phase III trial is studying endoscopy every 2 years to see how well it works compared with endoscopy only as needed in monitoring patients with Barrett esophagus.

Detailed description

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).

Conditions

• Esophageal Cancer
• Precancerous Condition

Interventions

Type	Name	Description
PROCEDURE	2 yearly endoscopy	2 yearly endoscopy versus endoscopy at need
PROCEDURE	comparison of screening methods	2 yearly endoscopy versus endoscopy at need
PROCEDURE	diagnostic endoscopic procedure	2 yearly endoscopy versus endoscopy at need
PROCEDURE	endoscopic biopsy	2 yearly endoscopy versus endoscopy at need
PROCEDURE	endoscopic procedure	2 yearly endoscopy versus endoscopy at need
PROCEDURE	quality-of-life assessment	QOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need
PROCEDURE	screening method	All Barretts patients to be screened

Timeline

• Start date: 2009-03-01
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2009-10-01
• Last updated: 2017-08-22

Locations

1 site across 1 country: United Kingdom