Evaluating Outcomes in Patients with Barrett's Esophagus Undergoing Treatment with Resection and Endoscopic Ablation Techniques, Treat-Be Study

PRIMARY OBJECTIVES:

I. To report on long-term effectiveness or durability of endoscopic eradication therapy (EET) in Barrett's esophagus (BE) related neoplasia.

II. To assess quality of life (QOL) in patients undergoing endoscopic eradication therapies for Barrett’s associated neoplasia.

III. To report on the recurrence rate of neoplasia and intestinal metaplasia and median time to recurrence.

IIIa. To provide evidence to help synthesize recommendations for surveillance post-EET in patients achieving complete eradication of intestinal metaplasia (CE-IM).

IV. To identify predictors associated with recurrence and persistence of neoplasia and intestinal metaplasia (IM) in patients undergoing EET.

V. To determine adverse event rates associated with EET for BE associated neoplasia and esophageal cancer (EAC).

VI. To determine the frequency and risk factors associated with subsquamous IM and define the histologic changes within the neosquamous epithelium post-EET.

VII. To determine the prevalence and incidence of dysplasia and EAC in a large cohort of patients with BE.

VIIa. To determine health-care utilization including endoscopic surveillance practices and outcomes (dysplasia/cancer and survival) in BE patients with and without neoplasia.

VIII. To determine risk factors for BE, BE related neoplasia and EAC and the magnitude of the association of selected factors such as age, gender, ethnicity, body mass index (BMI), tobacco use, alcohol use, gastroesophageal reflux disease (GERD) symptoms, metabolic syndrome, use of medications (aspirin, non steroidal anti-inflammatory drugs, anti-hyperglycemic medications, statins), and endoscopic findings such as length of BE and presence of hiatal hernia to the risk of progression to BE related neoplasia and EAC.

IX. To determine the impact of endoscopic and radiologic imaging modalities in the accurate diagnosis and staging of BE associated neoplasia and EAC.

X. To determine if early screening with available technologies can identify patients earlier with Barrett’s associated neoplasia who may benefit from EET.

XI. To assess the role of new technologies such as volumetric laser endomicroscopy/optical coherence tomography (VLE/OCT) and confocal laser endomicroscopy in identifying recurrence (both mucosal and subepithelial) post-eradication.

OUTLINE:

Patients complete questionnaires at each standard of care EET appointment every 2-3 months until there is no further evidence of BE.