Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?

Purpose: We propose a study comparing the morphological and functional aspects of the
neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE)
to that of native squamous epithelium in normal controls as well as gastroesophageal reflux
disease (GERD), non-BE subjects.

Participants: Eligible subjects will be women and men between the ages of 18-80, with one of
the following:

1. Two or greater cm of dysplastic BE, who will undergo or have undergone radiofrequency
ablation for BE at UNC, or

2. Diagnosed with GERD per a gastrointestinal (GI) physician undergoing upper endoscopy
for other indications at UNC, or

3. Non-GERD controls per a GI physician with normal esophageal mucosa undergoing upper
endoscopy for other indications at UNC.

Procedures (methods): Esophageal biopsies will be obtained specifically for research
purposes before ablation therapy or, in subjects not receiving ablative therapy, after
completion of the clinically indicated procedure and before withdrawal of the endoscope.
Information from the medical record or from patient interview will be obtained regarding
diagnosis (Barrett's esophagus, GERD, etc), and a questionnaire administered regarding the
duration and frequency of reflux symptoms and complications of reflux disease. Subjects who
are enrolled in the pre-ablation group will have additional biopsies and questionnaires
administered during scheduled follow-up visits. On the last follow-up visit, this group will
also undergo impedance-pH testing using standard methods, to assess for degree of control of
esophageal acid exposure, and for number, duration and symptom correlation of non-acid
reflux events.

Inclusion:

Eligible subjects will be mentally competent women and men between the ages of 18-80, able
to speak and read English and who meet one of the following criteria:

- Two or greater cm of dysplastic Barrett's Esophagus (BE), who will undergo or have
undergone radiofrequency ablation (RFA) for BE at the University of North Carolina,
Chapel Hill (UNC), or

- Diagnosed with gastroesophageal reflux disease (GERD) per a GI physician undergoing
upper endoscopy (EGD) for other indications at UNC, or

- Non-GERD controls per a GI physician with normal esophageal mucosa undergoing upper
endoscopy for other indications at UNC.

Exclusion:

- Subjects with a bleeding diathesis or other contraindication of endoscopic biopsy.

- Current use of warfarin, heparin, and/or low molecular weight heparin (requires
discontinuation of medication 5 days prior to and 7 days after EGD).

- Pregnant women