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Completed

NCT Number: NCT00513331

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.

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Carcinoma Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders GERD Gastroesophageal Reflux Gastrointestinal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Valley Health System - The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, 07652, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

endoscopy

Procedure

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

Procedure

Ablation using the HALO 360 system according to protocol established by BARRX, Inc.

Endoscopic mucosal resection protocol

Procedure

Excision of lesion using DUETTE, marketed by Wilson-Cook

Primary outcomes

  1. 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

Secondary outcomes

  1. To collect and store patient data regarding their Barrett's esophagus

    Time frame: Througout Study

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Valley Health System

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Aug 8, 2007
Registry last updated
Jan 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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