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Sponsored by: |
Valley Health System |
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Information provided by: | Valley Health System |
ClinicalTrials.gov Identifier: | NCT00513331 |
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 |
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Barrett's Esophagus GERD |
Procedure: Endoscopy Procedure: Radiofrequency ablation protocol Procedure: Endoscopic mucosal resection protocol |
Phase II Phase III |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | The Valley Hospital Center for Barrett's Esophagus and Gastroesophageal Reflux Disease (GERD) |
Tissue and blood for future analysis
Estimated Enrollment: | 100 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | August 2017 |
Groups/Cohorts | Assigned Interventions |
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Algorithm #1
Patients without visable lesions
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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.
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Algorithm #2
Patients with a visable lesion that is less than 1cm
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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
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Algorithm #3
Patients with a visable lesion greater than 1cm
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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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Referred Patients with underlying disease of BE or GERD
Inclusion Criteria:
Exclusion Criteria:
Contact: Dana Inzeo, APN | 201-634-5443 | dinzeo@valleyhealth.com |
Contact: Cheryl Parish, RN, MBA | 201-634-5792 | cparish@valleyhealth.com |
United States, New Jersey | |
Valley Health System - The Valley Hospital - Luckow Pavilion | Recruiting |
Paramus, New Jersey, United States, 07652 | |
Contact: Dana Inzeo, APN 201-634-5789 dinzeo@valleyhealth.com | |
Principal Investigator: Robert J. Korst, MD |
Principal Investigator: | Robert J. Korst, MD | Valley Health Systems/ The Valley Hospital |
Responsible Party: | Oncology Services ( Nancy Librera, Administrator ) |
Study ID Numbers: | VHS07.0017 |
Study First Received: | August 6, 2007 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00513331 |
Health Authority: | United States: Institutional Review Board |
Barrett's Esophagus GERD Carcinoma |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Digestive System Abnormalities Esophageal disorder Gastrointestinal Diseases |
Barrett Esophagus Esophageal Diseases Congenital Abnormalities Gastroesophageal Reflux Carcinoma |