Barrett's Esophagus & Gastroesophageal Reflux Disease

Completed

• Conditions: GERD; Barrett's Esophagus
• Interventions: Procedure: Endoscopy; Procedure: Radiofrequency ablation protocol; Procedure: Endoscopic mucosal resection protocol

• Registration Number: NCT00513331
• Lead Sponsor: Valley Health System

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-07
• Study First Posted: 2007-08-08
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-31
• Last Update Posted: 2014-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Algorithm #1	Endoscopy	Patients without visable lesions
Algorithm #2	Radiofrequency ablation protocol	Patients with a visable lesion that is less than 1cm
Algorithm #2	Endoscopic mucosal resection protocol	Patients with a visable lesion that is less than 1cm
Algorithm #3	Radiofrequency ablation protocol	Patients with a visable lesion greater than 1cm
Algorithm #3	Endoscopic mucosal resection protocol	Patients with a visable lesion greater than 1cm
Algorithm #2	Endoscopy	Patients with a visable lesion that is less than 1cm
Algorithm #3	Endoscopy	Patients with a visable lesion greater than 1cm

Primary Outcome Measures

Name	Time	Method
To standardize physician recommendations and provide cutting edge technology to patients with BE and GERD, and establish a Valley Hospital Center for Barrett's Esophagus and GERD	Until study complete

Secondary Outcome Measures

Name	Time	Method
To collect tissue specimens (biopsy and surgical specimens) for use in proteomic analysis to investigate the dysplasia/carcinoma sequence at the protein expression level.	throughout Study
To collect and store patient data regarding their Barrett's esophagus	Througout Study
To assess clinical outcomes of patients enrolled in The Valley Hospital Center for Barrett's Esophagus and GERD, and modify algorithms as appropriate.	Annually

Trial Locations

Locations (1)

Valley Health System - The Valley Hospital - Luckow Pavilion; 🇺🇸 Paramus, New Jersey, United States