Research Study Summary
Barrett's Esophagus & Gastroesophageal Reflux Disease
This is a study of Barrett's Esophagus (BE) and
Gastroesophageal Reflux Disease (GERD). It aims to look at the long
term efficacy of evidence-based cutting edge diagnostic and
therapeutic algorithms and techniques such as radiofrequency
ablation, endoscopic mucosal resection and surveillance endoscopy
with biopsy. Additionally, biological analyses will be performed in
hopes of identifying biomarkers associated with the progression of
BE to esophageal cancer.
- Male or female, age 18 to 85.
- Patient must have Barrett's Esophagus.
- Patients may be enrolled based on previous endoscopy reports
and/or pathology reports. It is not necessary that each patient
have endoscopy for the sole purpose of enrollment.
- Must agree to allow their clinical information to be collected,
stored, analyzed and reported.
- Must allow portions of their biopsy/surgical specimens to be
collected, stored, analyzed and reported.
- Must agree to fill out patient questionnaires in conjunction
with the research study assistant assigned to this protocol (either
in person or via telephone contact) at designated
Patient Exclusion Criteria:
- Intestinal metaplasia of the cardia, without an esophageal
- Unable to provide informed consent.
- Unable or unwilling to undergo endoscopic procedures.
Barrett's esophagus (BE) is a known premalignant condition of
the esophagus, predisposing to the development of esophageal
adenocarcinoma. BE represents a change in the lining (mucosa) of
the esophagus which is known to be produced as a result of chronic
gastroesophageal reflux. The current standard of care for patients
with BE includes serial performance of upper endoscopy with
multiple biopsies, performed at designated time intervals. However,
the emergence of new technologies for the management of this
condition has made the care of these patients non-uniform, and
subject to biases of individual treating physicians.
The protocol at The Valley Hospital and Blumenthal Cancer Center
aims to standardize the management of patients with Barrett's
esophagus, with and without dysplasia, using evidence-based,
cutting edge diagnostic and therapeutic algorithms and techniques
such as radiofrequency ablation, endoscopic mucosal resection, and
surveillance endoscopy with biopsies. If biopsies suggest the
development of carcinoma or high grade dysplasia surgical removal
of the esophagus is recommended. This study aims to look at the
long-term efficacy of these procedures. In addition, data regarding
clinical outcomes will be collected as well as blood, tissue and
surgical specimens for proteomic analysis in hopes of identifying
biomarkers associated with the progression of dysplasia to
adenocarcinoma. Although patients will ultimately make their own
informed decisions regarding the management of their BE, this
protocol serves to unify physician recommendations, and allows for
the collection and interpretation of data.
To Learn more
CW ID: 120691
Date Last Changed:
July 25, 2013