GERD Clinical Trial
Official title:
The Valley Hospital Center for Barrett's Esophagus and Gastroesophageal Reflux Disease (GERD)
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.
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