Barrett's Esophagus & Gastroesophageal Reflux Disease

Valley Health System

Status: Completed

Conditions: GERD; Barrett's Esophagus

Treatments: Procedure: Endoscopic mucosal resection protocol; Procedure: Radiofrequency ablation protocol; Procedure: Endoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT00513331

VHS07.0017

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 timepoints.

Exclusion criteria

• Intestinal metaplasia of the cardia, without an esophageal columnar lining.
• Unable to provide informed consent.
• Unable or unwilling to undergo endoscopic procedures.

Trial design

125 participants in 3 patient groups

Algorithm #1

Description:

Patients without visable lesions

Treatment:

Procedure: Endoscopy

Algorithm #2

Description:

Patients with a visable lesion that is less than 1cm

Treatment:

Procedure: Endoscopic mucosal resection protocol

Procedure: Radiofrequency ablation protocol

Procedure: Endoscopy

Algorithm #3

Description:

Patients with a visable lesion greater than 1cm

Treatment:

Procedure: Endoscopic mucosal resection protocol

Procedure: Radiofrequency ablation protocol

Procedure: Endoscopy