NCT00513331

Barrett's Esophagus & Gastroesophageal Reflux Disease

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: Valley Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Barrett's Esophagus
• GERD

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-07-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2007-08-08
• Last updated: 2014-01-01

Locations

1 site across 1 country: United States