High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia

Our central hypothesis is that HRME can improve the efficiency and clinical impact of endoscopic screening and surveillance of esophageal squamous cell neoplasia by providing in-vivo optical biopsies comparable to standard histology. Specifically, HRME will allow more detailed evaluation of Lugol's abnormal areas, allowing selective biopsy or removal of neoplastic mucosa. We hypothesize that this will improve the accuracy and diagnostic yield of mucosal sampling. We also hypothesize the HRME will provide additional, more accurate information regarding the presence of neoplasia that will impact upon the physician's decision to obtain a mucosal biopsy or perform endoscopic therapy (endoscopic mucosal resection or ablation). This could potentially minimize the number of unnecessary biopsies and enable the physician to perform endoscopic therapy at the time of the initial examination, rather than delaying endoscopic treatment to another procedure following pathologic confirmation of the initial biopsies. Primary Aims: 1. To compare the efficiency of HRME + Lugol's chromoendoscopy (HRME + LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia. Efficiency will be defined as: 1. Diagnostic Yield: The number of neoplastic biopsies/total number of biopsies obtained in patients who receive biopsies. 2. 'Patients saved': # patients who receive no biopsies 3. Procedure time: Total procedure time in the HRME-LC arm compared to the LC arm. 2. 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. 3. 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: (a) To determine the sensitivity, specificity, positive and negative predictive value for the identification of neoplasia on a per biopsy and per patient analysis 4. To determine the cost-effectiveness of HRME-LC to LC alone for the endoscopic screening and surveillance of esophageal squamous neoplasia in the US and China.