Barrett's Esophagus & Gastroesophageal Reflux Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valley Health System
ClinicalTrials.gov Identifier:
NCT00513331
First received: August 6, 2007
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Barrett's Esophagus
GERD
Procedure: Endoscopy
Procedure: Radiofrequency ablation protocol
Procedure: Endoscopic mucosal resection protocol
Phase 2
Phase 3

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Valley Hospital Center for Barrett's Esophagus and Gastroesophageal Reflux Disease (GERD)

Resource links provided by NLM:


Further study details as provided by Valley Health System:

Primary Outcome Measures:
  • 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 [ Time Frame: Until study complete ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To collect and store patient data regarding their Barrett's esophagus [ Time Frame: Througout Study ] [ Designated as safety issue: No ]
  • To collect tissue specimens (biopsy and surgical specimens) for use in proteomic analysis to investigate the dysplasia/carcinoma sequence at the protein expression level. [ Time Frame: throughout Study ] [ Designated as safety issue: No ]
  • To assess clinical outcomes of patients enrolled in The Valley Hospital Center for Barrett's Esophagus and GERD, and modify algorithms as appropriate. [ Time Frame: Annually ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Tissue and blood for future analysis


Enrollment: 125
Study Start Date: July 2007
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Algorithm #1
Patients without visable lesions
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.
Algorithm #2
Patients with a visable lesion that is less than 1cm
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.
Procedure: Radiofrequency ablation protocol
Ablation using the HALO 360 system according to protocol established by BARRX, Inc.
Procedure: Endoscopic mucosal resection protocol
Excision of lesion using DUETTE, marketed by Wilson-Cook
Algorithm #3
Patients with a visable lesion greater than 1cm
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.
Procedure: Radiofrequency ablation protocol
Ablation using the HALO 360 system according to protocol established by BARRX, Inc.
Procedure: Endoscopic mucosal resection protocol
Excision of lesion using DUETTE, marketed by Wilson-Cook

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Referred Patients with underlying disease of BE or GERD

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513331

Locations
United States, New Jersey
Valley Health System - The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
Valley Health System
Investigators
Principal Investigator: Robert J. Korst, MD Valley Health Systems/ The Valley Hospital
  More Information

No publications provided

Responsible Party: Valley Health System
ClinicalTrials.gov Identifier: NCT00513331     History of Changes
Other Study ID Numbers: VHS07.0017
Study First Received: August 6, 2007
Last Updated: December 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Valley Health System:
Barrett's Esophagus
GERD
Carcinoma

Additional relevant MeSH terms:
Gastroesophageal Reflux
Barrett Esophagus
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Digestive System Abnormalities

ClinicalTrials.gov processed this record on September 16, 2014