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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anandasabapathy, Sharmila, M.D.
• Collaborators: Baylor College of Medicine; William Marsh Rice University
• Treatments: Proflavine

Criteria

Inclusion Criteria:

• outpatients with > 1 cm biopsy-proven Barrett's Esophagus who are undergoing standard of care endoscopic surveillance for metaplasia, dysplasia, or neoplasia.

Exclusion Criteria:

• Allergy or prior reaction to the fluorescent contrast agent proflavine

• Patients who are unable to give informed consent.

• Known advanced adenocarcinoma of the distal esophagus, or dysplastic/suspected malignant esophageal lesion > 2 cm in size not amenable to EMR

• Patients with a history of a severe allergic reaction (anaphylaxis)

• Patients unable to undergo routine endoscopy with biopsy :

• Women who are pregnant or breastfeeding

• Prothrombin Time > 50% of control; PTT > 50 sec, or INR > 2.0)

• Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other

• Patients with known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope

• Patients with known severe esophagitis

• Patients with suspected but no biopsy confirmed BE