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

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)

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