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

Barrett's Esophagus Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Barrett's Esophagus

• NCT number: NCT02018367
• Study type: Interventional
• Source: Anandasabapathy, Sharmila, M.D.
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2012
• Completion date: December 2021