This phase II trial studies how well high-resolution microendoscopy works compared to standard white-light endoscopy in diagnosing esophageal cancer in participants with Barrett esophagus. High resolution microendoscopy involves spraying a dye called proflavine hemisulfate on the esophagus and using a very powerful microscope to highlight abnormal areas. A standard endoscopy involves visual examination of the esophagus using a flexible, thin tube (endoscope) with a light and a small camera at the end. It is not yet known whether high resolution microendoscopy is better than standard white-light endoscopy in diagnosing esophageal cancer in participants Barrett esophagus.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02018367.
PRIMARY OBJECTIVES:
I. To compare the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of high-resolution microendoscopy (HRME) with directed biopsy to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of Barrett esophagus (BE)-associated neoplasia in flat mucosa as well as mucosal lesions.
II. To prospectively assess the potential clinical impact of HRME on the diagnosis and endoscopic surveillance of BE-associated neoplasia by determining if HRME alters the decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR) and changes the total number of total mucosal biopsies taken per procedure.
III. To determine the diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of HRME for the in-vivo diagnosis of neoplasia in a surveillance population of patients with BE using histopathologic diagnosis of mucosal biopsies as the reference standard.
IV. To compare the total procedure time for imaging and mucosal biopsy acquisition of HRME with WL, stratified by length of BE (less than 3 cm and greater than 3 cm) and to determine the average HRME imaging time.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP A: Participants undergo standard of care high resolution white-light endoscopy and biopsies.
GROUP B: Participants receive proflavine hemisulfate topically on the esophagus and undergo HRME. Participants may then undergo standard of care biopsies.
After completion of endoscopy procedures, participants will be followed up within 2-5 days.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorSharmila Anandasabapathy
