Results promising for treatment of Barrett's esophagus with minimally invasive radiofrequency ablation therapy

Friday, April 27, 2007

SCOTTSDALE, Ariz. — Just over a year ago, some 100 patients across the U.S. with Barrett's esophagus, a condition that can potentially lead to esophageal cancer, agreed to participate in a multi-center clinical trial in which radiofrequency ablation was administered to destroy abnormal cells in the esophagus.

Now the results are in. The minimally invasive procedure that can be done as an outpatient, allowing patients to go home the same day, was successful in 70 percent of the patients, leaving them completely free of the disease.

More than 3 million adults in the U.S. have Barrett's esophagus, a complication of gastroesophageal reflux disease, commonly called GERD. Left untreated, the disease can progress to esophageal cancer, the fastest growing cancer in the U.S. in terms of new cases per year, according to the American Cancer Society. Symptoms may include heartburn and acid reflux - common indicators of GERD. Additional symptoms include trouble swallowing, vomiting blood and loss of appetite.

First author of the study, Virender K. Sharma, M.D., gastroenterologist at Mayo Clinic in Arizona, is encouraged by the results, calling the study "a very important milestone in the advancement of this ablative technology for our patients with Barrett's esophagus." Sharma explained that the standard of care for Barrett's has been "surveillance endoscopy," involving biopsies of the diseased tissue over the patient's lifetime, or until the disease progressed to a more dangerous form. Barrett's esophagus can lead to dysplasia and cancer.

Radiofrequency ablation uses heat that is delivered through bipolar electrode coils on the surface of a small balloon catheter. The energy can be precisely controlled to the point where cells only one or two layers deep can be ablated.

Study patients were administered conscious sedation and reported minimal post-procedural discomfort. The procedure takes about 45 minutes and there are no incisions. Patients can return to work or their normal activity the following day. At 12 months following the study, 70 percent of the patients, ranging in age from 18 to 75, experienced complete elimination of their Barrett's esophagus. The remaining patients had near complete resolution of their disease.

The study, formally titled Circumferential Endoscopic Radiofrequency Ablation of Barrett's Esophagus Using a Balloon-Bassed System: 1-Year follow-up of 100 Patients, involved patients from eight U.S. medical centers between September 2003 and September 2005.

David E. Fleischer, M.D., gastroenterologist, also at Mayo Clinic in Arizona and a co-author of the study, said, "Results of this important study suggest that we can safely and proactively eliminate Barrett's esophagus at the very earliest stage. It will be the responsibility of the gastroenterology community to determine what role this procedure will have for patients with Barrett's." The treatment with Radiofrequency Ablation "represents a welcome change in the management strategy for our patients with Barrett's esophagus," said H. Jae Kim, M.D., Gastroenterology at Mayo Clinic in Arizona.

Mayo Clinic has performed the most radiofrequency ablation procedures to treat Barrett's esophagus of all the academic medical centers in the U.S.

Mayo Clinic is the first and largest integrated, not-for-profit group practice in the world. As a leading academic medical center in the Southwest, Mayo Clinic focuses on providing specialty and surgical care in more than 65 disciplines at its outpatient facility in north Scottsdale and at Mayo Clinic Hospital. The 208-licensed bed hospital is located at 56th Street and Mayo Boulevard (north of Bell Road) in northeast Phoenix, and provides inpatient care to support the medical and surgical specialties of the clinic, which is located at 134th Street and Shea Boulevard in Scottsdale.

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