Barrett's Esophagus & Gastroesophageal Reflux Disease

GERD Clinical Trial

Official title:

The Valley Hospital Center for Barrett's Esophagus and Gastroesophageal Reflux Disease (GERD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513331
• Other study ID #: VHS07.0017
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 6, 2007
• Last updated: December 31, 2013
• Start date: July 2007
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Valley Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Gastroesophageal Reflux
• GERD

Intervention

Procedure:
• Endoscopy
Initial Assessment for lesions can be based on information obtained from previous upper endoscopies and or pathology reports. Repeat Endoscopic assessments are based on initial and follow-up assessments.
• Radiofrequency ablation protocol
Ablation using the HALO 360 system according to protocol established by BARRX, Inc.
• Endoscopic mucosal resection protocol
Excision of lesion using DUETTE, marketed by Wilson-Cook

Locations

Country	Name	City	State
United States	Valley Health System - The Valley Hospital - Luckow Pavilion	Paramus	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Valley Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To collect and store patient data regarding their Barrett's esophagus		Througout Study	No
Secondary	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	No
Secondary	To assess clinical outcomes of patients enrolled in The Valley Hospital Center for Barrett's Esophagus and GERD, and modify algorithms as appropriate.		Annually	Yes