Cryotherapy Ablation of Barrett's Esophagus and Early Esophageal Cancer
Barrett's esophagus (BE) with high grade dysplasia (HGD) is a precursor of esophageal
adenocarcinoma. Eliminating this condition may control the current rapid rise of
adenocarcinoma. Ablative techniques are attempted to avoid the high morbidity and mortality
of esophagectomy or for use in patients who cannot undergo surgery. Current ablative
techniques have achieved mucosal ablation with variable success but are associated with high
cost, patient discomfort and/or significant complications. A novel device which sprays
liquid nitrogen through an upper endoscope (cryotherapy) has been shown to be a safe and
effective procedure to ablate the esophageal mucosa in swine and dog models and in pilot
studies in humans. Successful reversal of BE, LGD, HGD and superficial adenocarcinoma and
squamous cell carcinoma have been demonstrated when cryotherapy with this device is followed
by healing of the esophageal lining in a low acid environment.
This study is undertaken to demonstrate the efficacy and safety in the ablation of Barrett's
esophagus with high-grade, neoplasia, and severe esophageal squamous dysplasia and to
confirm preliminary results in humans.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
HGD or inoperable intramucosal or submucosal carcinoma ans severe squamous dysplasia: measure of reduction in size of HGD or carcinoma
Bruce D Greenwald, M.D.
University of Maryland
United States: Institutional Review Board
|University of Maryland School of Medicine and Greenebaum Cancer Center||Baltimore, Maryland 21201-1505|