Narrow Band Imaging Project on Barrett's Esophagus

This is a multicenter, prospective, double-blinded study of NBI images from 50 patients
enrolled in the study. Patients undergoing BE screening and BE surveillance will be enrolled
into the study. After meeting eligibility criteria, and obtaining an informed consent,
patients will undergo their routine upper endoscopic examination using white light endoscopy.
During the course of the upper endoscopy, the BE surface patterns will be carefully examined
with the endoscope in overview mode (with the endoscope in the center of the esophageal
lumen) and then in close proximity to the BE surface (approximately 3-5 mm away from the
mucosa). In each of these positions, a maximum of 4 high quality images will be obtained from
different surface patterns initially with WLE and then using NBI. Image capture will be
standardized. All the images will be classified based upon a simplified NBI classification
system using two main criteria:(1)mucosal pattern(regular/irregular/uncertain) and
(2)vascular pattern (regular/irregular/uncertain). All images will be captured using a
high-definition, NBI endoscope (190 endoscopes-GIF-HQ 190 [dual focus],Olympus Inc) and
stored in the high quality TIFF format. After images have been obtained, target biopsies will
be obtained from each area and submitted for histopathological evaluation in separate jars.
From the reports on NBI patterns from the images by Gastroenterologist and corresponding
histopathological details, the accuracy and interobserver agreement of this NBI
classification system will be determined.

Inclusion Criteria:

- Patients age: ≥ 18 years

- Undergoing endoscopy for surveillance or endoscopic treatment of Barrett's esophagus

- Ability to take oral proton pump inhibitor

- For female subjects of childbearing potential, a negative urine pregnancy test within
2 weeks of enrollment and any subsequent endoscopy encounter

- Subject is eligible for treatment and follow-up endoscopy and biopsy as required by
the investigational plan

- Ability to discontinue Aspirin/NSAIDs/Clopidogrel 7 days before and after all ablation
procedures

- Ability to provide written, informed consent and understands the responsibilities of
trial participation

Exclusion Criteria:

- The subject is pregnant or planning a pregnancy during the study period (12 months
after treatment)

- Esophageal stricture preventing passage of endoscope or catheter

- Active erosive esophagitis

- Prior endoscopic therapy with endoscopic mucosal resection, radiofrequency ablation,
etc.

- History of esophageal varices or coagulopathy

- Prior radiation therapy to the esophagus, except head and neck region radiation
therapy.

- Evidence of esophageal varices during treatment endoscopy

- Subject has a known history of unresolved drug or alcohol dependency that would limit
ability to comprehend or follow instructions related to informed consent,
post-treatment instructions, or follow-up guidelines

- The subject is currently enrolled in an investigational drug or device trial that
clinically interferes with the current study.

- Subject suffers from psychiatric or other illness deemed by the investigator as an
inability to comply with protocol