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|Covidien Announces Clinical Trial Data Showing Endoscopic Ablation Therapy Eliminates Precancerous Esophageal Tissue and Significantly Reduces Disease Progression|
Endoscopic ablation in patients with Barrett’s esophagus containing confirmed low-grade dysplasia reduces the relative risk for disease progression by 94% as compared to controls
The SURF Trial* (SUrveillance vs. RadioFrequency ablation) included 136 patients with Barrett’s esophagus containing confirmed low-grade dysplasia. Upon enrollment, patients were randomly assigned to receive either endoscopic ablation therapy and subsequent endoscopic observation (treatment group) or endoscopic observation alone (control group). Tissue samples (biopsies) were obtained at regular intervals after enrollment to assess for the presence of Barrett’s tissue, dysplasia and esophageal cancer.
The primary endpoint of the trial was a comparison of the risk of disease progression over time between the ablation and control groups. Disease progression was defined as the development of either high-grade dysplasia or esophageal cancer during follow-up. The authors reported that endoscopic ablation therapy resulted in a 94% relative risk reduction in disease progression, compared to controls (1.5% progression in ablation group vs. 25.0% progression in control group) over a two-year follow-up period.
Other endpoints included resolution of Barrett’s tissue and occurrence of adverse events. At last endoscopy visit, 90% of patients treated with ablation were free of all signs of Barrett’s esophagus tissue, while none of the patients in the control group demonstrated resolution of Barrett’s tissue. The most common adverse event was esophageal narrowing in the ablation group, which occurred in 7 patients (10.3%) and was resolved with endoscopic dilation.
“In patients with Barrett’s esophagus containing confirmed low-grade
dysplasia, endoscopic ablation significantly reduced disease progression
to high-grade dysplasia and esophageal cancer, as compared to
surveillance alone,” said principal investigator
The study, entitled “Radiofrequency Ablation in Barrett’s Esophagus with
Confirmed Low-Grade Dysplasia: Results of a European Multicenter
Randomized Controlled Trial (SURF),” was conducted at nine European
medical centers with expertise in the management of Barrett’s esophagus,
dysplasia and cancer. Dr. Bergman’s colleague,
“This trial adds very important new information to the management
algorithm for patients with Barrett’s esophagus containing confirmed
low-grade dysplasia,” commented
Barrett’s esophagus develops as a result of chronic injury from gastroesophageal reflux disease. The normal esophageal lining is replaced with abnormal cells (Barrett’s tissue), predisposing the patient to a risk for developing adenocarcinoma (cancer) of the esophagus. Patients with Barrett’s who ultimately develop cancer typically do so through a series of steps, starting with early Barrett’s, proceeding to low-grade dysplasia or high-grade dysplasia and then, finally, progressing to cancer.
*The SURF Trial was supported by funds, products and collaboration