endoscopy every 2 years or only as needed in monitoring patients with barrett esophagus

Conditions: Esophageal Cancer; Precancerous Condition

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.

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 (\ 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).

Eligibility criteria:
disease characteristics: * 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

Keywords: esophageal cancer adenocarcinoma of the esophagus barrett esophagus