Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
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To estimate the cost-effectiveness of endoscopic surveillance every 2 years as compared to endoscopy at need only.
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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.
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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.
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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.
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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).
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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.
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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.
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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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 2 yearly endoscopies Two years endoscopies |
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
|
| Experimental: endoscopy at need Endoscopy only when patient reports symptoms |
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
|
Outcome Measures
Primary Outcome Measures
- Overall survival []
Secondary Outcome Measures
- Cost-effectiveness []
- Incidence of esophageal cancer, gastric or esophageal cancer, or all cancers []
- Time to diagnosis of esophageal adenocarcinoma []
- Stage of esophageal adenocarcinoma at diagnosis using TNM staging []
- Morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions []
- Frequency of endoscopy []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed circumferential Barrett metaplasia meeting 1 of the following criteria:
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At least 1 cm from the gastro-esophageal junction
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At least a 2 cm non-circumferential tongue of Barrett metaplasia
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Undergone endoscopy within the last 2 years to confirm Barrett metaplasia and exclude high-grade dysplasia and carcinoma
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No known high-grade dysplasia or carcinoma
PATIENT CHARACTERISTICS:
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Resident of the United Kingdom
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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
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Able to undergo endoscopy
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No medical conditions that would make endoscopy difficult or hazardous
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gloucestershire Royal Hospital | Gloucester | England | United Kingdom | GL1 3NN |
Sponsors and Collaborators
- Gloucestershire Hospitals NHS Foundation Trust
Investigators
- Principal Investigator: Hugh Barr, Gloucestershire Hospitals NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NHS-GRH-HTA-05/12/01
- CDR0000649890
- ISRCTN54190466