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
ORLANDO, Fla.--(BUSINESS WIRE)-- Covidien (NYS: COV) , a leading global provider of healthcare products, today announced that results from a prospective, multicenter, randomized, controlled clinical trial show that endoscopic ablation therapy using the Barrx™ RF Ablation System is effective at eliminating Barrett's esophagus, a pre-cancerous condition of the esophagus, and preventing disease progression.
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 Jacques Bergman, M.D., Ph.D., Professor of Gastrointestinal Endoscopy, Director of Endoscopy, Academic Medical Center, Amsterdam, the Netherlands. "The difference in the disease progression outcome between the two groups was so large, in fact, that the data safety monitoring board overseeing the trial recommended early stoppage of the trial, and patients in the control group will now be offered endoscopic ablation."
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, Kai Yi N. Phoa, M.D., presented the outcomes data yesterday (Abstract #1004) at Digestive Disease Week 2013, part of an American Gastroenterological Association research forum held here this week.
"This trial adds very important new information to the management algorithm for patients with Barrett's esophagus containing confirmed low-grade dysplasia," commented David S. Utley, M.D., Chief Medical Officer, Covidien GI Solutions. "Until now, there was some level of uncertainty regarding the optimal management strategy for a patient with low-grade dysplasia. We believe that this randomized, controlled trial provides the highest level of evidence that disease progression in this population is high over two years when observation alone is employed, and that this progression risk can be significantly reduced if the patient is treated proactively with endoscopic ablation."
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 provided by Covidien.
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2012 revenue of $11.9 billion, Covidien has 43,000 employees worldwide in 70 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.
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