NCT02018367

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Anandasabapathy, Sharmila, M.D. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Barrett's Esophagus

Interventions

Type	Name	Description
DRUG	Proflavine, high resolution imaging	5-10mL of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the biopsy channel of the endoscope and gently placed against the mucosa. The endoscopist will image each discrete lesion observed during white light endoscopy. For each HRME imaged area, an optical read will be obtained followed by a tissue biopsy.

Timeline

• Start date: 2012-09-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2013-12-23
• Last updated: 2021-01-14

Locations

1 site across 1 country: United States