An observational study in Barrett's Esophagus and GERD, sponsored by Valley Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-01.
Sponsored by Valley Health System · Observational
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.
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.
310 studies on the registry are indexed under Barrett Esophagus; 64 are open to participants now.
This study's enrollment of 125 is close to the median of 127 across 115 observational studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →Valley Health System is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Referred Patients with underlying disease of BE or GERD
Exclusion Criteria:
Patients without visable lesions
Procedure: Endoscopy
Patients with a visable lesion that is less than 1cm
Procedure: Endoscopy · Procedure: Radiofrequency ablation protocol · Procedure: Endoscopic mucosal resection protocol
Patients with a visable lesion greater than 1cm
Procedure: Endoscopy · Procedure: Radiofrequency ablation protocol · Procedure: Endoscopic mucosal resection protocol
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.
Ablation using the HALO 360 system according to protocol established by BARRX, Inc.
Excision of lesion using DUETTE, marketed by Wilson-Cook
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
To collect and store patient data regarding their Barrett's esophagus
Time frame: Througout Study
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
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
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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