This phase II trial studies how well high resolution microendoscopy with proflavine hemisulfate works in diagnosing squamous cell cancer of the esophagus in participants undergoing standard chromoendoscopy. Standard chromoendoscopy is a procedure which helps doctors look at the inside of the esophagus using Lugol's solution as a dye or stain for abnormal areas that might be disease. High resolution microendoscopy using proflavine hemisulfate as a dye is similar, but may provide better images. It is not yet known whether high resolution microendoscopy with proflavine hemisulfate is better in diagnosing participants with squamous cell cancer of the esophagus.
Additional locations may be listed on ClinicalTrials.gov for NCT02029937.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To compare the efficiency of high-resolution microendoscope (HRME) + Lugol’s chromoendoscopy (HRME + LC) to that of Lugol’s chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia.
II. To prospectively determine the potential clinical impact of HRME + Lugol’s chromoendoscopy (HRME-LC) to Lugol’s chromoendoscopy (LC) by determining if HRME changes the decision to perform endoscopic therapy (endoscopic mucosal resection or ablation) or perform a mucosal biopsy.
III. To prospectively compare the performance characteristics of HRME-LC to LC for the prediction of squamous esophageal neoplasia in flat mucosa and mucosal lesions using histopathology as the gold standard
IV. To determine the sensitivity, specificity, positive and negative predictive value for the identification of neoplasia on a per biopsy and per subject analysis.
V. To determine the cost-effectiveness of HRME-LC to LC alone for the endoscopic screening and surveillance of esophageal squamous neoplasia in the United States (U.S.) and China.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP A: (HRME + LC): Participants undergo standard LC with Lugol's solution given topically on the esophageal tissue. Participants then undergo high resolution microendoscopy with proflavine hemisulfate given topically on the esophageal tissue, and biopsy retrieval if needed.
GROUP B: (LC): Participants undergo LC as in Group A and biopsy retrieval if needed.
Following completion of endoscopy, participants will be followed up within 7 days.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorSharmila Anandasabapathy
