Spots Global Cancer Trial Database for Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma

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Trial Identification

Brief Title: Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma

Official Title: Accuracy, Yield and Clinical Impact of a Low-Cost High Resolution Microendoscope in the Early Diagnosis of Esophageal Adenocarcinoma

Study ID: NCT02018367

Conditions

Barrett's Esophagus

Interventions

Proflavine, high resolution imaging

Study Description

Brief Summary: The overall goal of the study is to determine whether imaging with the low-cost High Resolution Microendoscope(HRME) will increase the efficiency and yield of the current standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide an in-vivo "optical biopsy" that will be comparable to gold standard histopathology and allow the endoscopist to make a more informed decision about whether to obtain a biopsy or even perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).

Detailed Description: Primary outcomes: * the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy - compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions * the clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia * does HRME alter the decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR) * the total number of total mucosal biopsies taken per procedure; does HRME alter the number of biopsies necessary? Secondary outcomes: * sensitivity, specificity, positive predictive value, and negative predictive value of HRME for the in-vivo diagnosis of neoplasia in a routine surveillance population of patients with BE (using histopathologic diagnosis of mucosal biopsies as the reference standard) * the total procedure time for imaging and mucosal biopsy acquisition of HRME - compared with WL, stratified by length of BE (\< 3 cm and \> 3cm)