Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

This is a longitudinal observational study were imaging procedures are allocated in a random
order to directly address the low sensitivity and specificity of enhanced macroscopic
endoscopic imaging devices by determining whether probe-based Confocal Laser Endomicroscopy
(pCLE), as a supplement to Narrow Band Imaging (NBI) can further improve sensitivity and
specificity to a level that would be acceptable to avoid random biopsy, and better direct
biopsy of suspicious areas. The study is also addressing pCLE as a supplement to standard
white light endoscopy and random biopsy alone. In fact, the study is powered to evaluate per
lesion sensitivity and specificity of confocal imaging as applied to lesions identified by
white light endoscopy. Therefore, the study addresses the shortcomings of standard white
light endoscopy (high number of random biopsies, less than ideal directed biopsy of
suspicious areas) and the primary shortcomings of Narrow Band Imaging (NBI) (low specificity
with resultant high false positives, again resulting in many unnecessary biopsies).

Inclusion Criteria:

1. Patients with documented or suspected Barrett's esophagus presenting for endoscopy

2. Age > 18 years

3. Ability to provide written, informed consent

Exclusion Criteria:

1. Presence of erosive esophagitis

2. Inability to obtain biopsies due to anticoagulation, varices, etc.

3. Allergy to fluorescein, pregnancy

4. Presence of an esophageal mass other than small 10mm or less nodules

5. Renal insufficiency