Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus
- Conditions
- Precancerous ConditionEsophageal Cancer
- Interventions
- Procedure: 2 yearly endoscopyProcedure: comparison of screening methodsProcedure: diagnostic endoscopic procedureProcedure: endoscopic biopsyProcedure: endoscopic procedureProcedure: quality-of-life assessmentProcedure: screening method
- Registration Number
- NCT00987857
- Lead Sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- 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.
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 yearly endoscopies diagnostic endoscopic procedure Two years endoscopies 2 yearly endoscopies endoscopic procedure Two years endoscopies 2 yearly endoscopies 2 yearly endoscopy Two years endoscopies 2 yearly endoscopies comparison of screening methods Two years endoscopies 2 yearly endoscopies screening method Two years endoscopies endoscopy at need diagnostic endoscopic procedure Endoscopy only when patient reports symptoms 2 yearly endoscopies endoscopic biopsy Two years endoscopies 2 yearly endoscopies quality-of-life assessment Two years endoscopies endoscopy at need endoscopic procedure Endoscopy only when patient reports symptoms endoscopy at need screening method Endoscopy only when patient reports symptoms endoscopy at need 2 yearly endoscopy Endoscopy only when patient reports symptoms endoscopy at need comparison of screening methods Endoscopy only when patient reports symptoms endoscopy at need endoscopic biopsy Endoscopy only when patient reports symptoms endoscopy at need quality-of-life assessment Endoscopy only when patient reports symptoms
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Time to diagnosis of esophageal adenocarcinoma Frequency of endoscopy Morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions Stage of esophageal adenocarcinoma at diagnosis using TNM staging Cost-effectiveness Incidence of esophageal cancer, gastric or esophageal cancer, or all cancers
Trial Locations
- Locations (1)
Gloucestershire Royal Hospital
🇬🇧Gloucester, England, United Kingdom