Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus
NCT ID: NCT00987857
Last Updated: 2017-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
3400 participants
INTERVENTIONAL
2009-03-31
2022-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Oesophagus
NCT02498041
Hyper-Spectral Endoscopy for Detection of Early Neoplasia in Barrett's Oesophagus
NCT06119906
Barrett's Esophagus in Olmsted County
NCT00943280
"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance
NCT02614703
Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus
NCT00903136
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
2 yearly endoscopies
Two years endoscopies
2 yearly endoscopy
2 yearly endoscopy versus endoscopy at need
comparison of screening methods
2 yearly endoscopy versus endoscopy at need
diagnostic endoscopic procedure
2 yearly endoscopy versus endoscopy at need
endoscopic biopsy
2 yearly endoscopy versus endoscopy at need
endoscopic procedure
2 yearly endoscopy versus endoscopy at need
quality-of-life assessment
QOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need
screening method
All Barretts patients to be screened
endoscopy at need
Endoscopy only when patient reports symptoms
2 yearly endoscopy
2 yearly endoscopy versus endoscopy at need
comparison of screening methods
2 yearly endoscopy versus endoscopy at need
diagnostic endoscopic procedure
2 yearly endoscopy versus endoscopy at need
endoscopic biopsy
2 yearly endoscopy versus endoscopy at need
endoscopic procedure
2 yearly endoscopy versus endoscopy at need
quality-of-life assessment
QOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need
screening method
All Barretts patients to be screened
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
2 yearly endoscopy
2 yearly endoscopy versus endoscopy at need
comparison of screening methods
2 yearly endoscopy versus endoscopy at need
diagnostic endoscopic procedure
2 yearly endoscopy versus endoscopy at need
endoscopic biopsy
2 yearly endoscopy versus endoscopy at need
endoscopic procedure
2 yearly endoscopy versus endoscopy at need
quality-of-life assessment
QOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need
screening method
All Barretts patients to be screened
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically confirmed circumferential Barrett metaplasia meeting 1 of the following criteria:
* At least 1 cm from the gastro-esophageal junction
* At least a 2 cm non-circumferential tongue of Barrett metaplasia
* Undergone endoscopy within the last 2 years to confirm Barrett metaplasia and exclude high-grade dysplasia and carcinoma
* No known high-grade dysplasia or carcinoma
PATIENT CHARACTERISTICS:
* Resident of the United Kingdom
* Informed of the risk of Barrett esophagus developing into esophageal cancer, either at the visit when the invitation letter is issued or on a documented previous occasion
* Able to undergo endoscopy
* No medical conditions that would make endoscopy difficult or hazardous
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gloucestershire Hospitals NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Clive Stokes
Professor Hugh Barr
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hugh Barr
Role: PRINCIPAL_INVESTIGATOR
Gloucestershire Hospitals NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. Gastroenterology. 2025 Apr 1:S0016-5085(25)00587-6. doi: 10.1053/j.gastro.2025.03.021. Online ahead of print.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000649890
Identifier Type: REGISTRY
Identifier Source: secondary_id
ISRCTN54190466
Identifier Type: -
Identifier Source: secondary_id
NHS-GRH-HTA-05/12/01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.