Barrett's esophagus eliminated when treated with ablation procedure

Monday, July 21, 2008

SCOTTSDALE, Ariz. —July 21, 2008 — One in 10 Americans experiences heartburn at least once a week, and many dismiss the malady as a mere annoyance, choosing to swallow antacids and get on with their lives.

But what they don't know can hurt them. Left untreated, the condition can lead to Barrett's esophagus, which in turn can put patients at risk for esophageal cancer, one of the most deadly forms of cancer.

Now a multi-center clinical trial led by David E. Fleischer, M.D., Gastroenterology, Mayo Clinic in Arizona, has revealed promising results in treatment of Barrett's esophagus. The study, released today by BARRX Medical, Inc., finds that the 98.4 percent of patients with Barrett's esophagus were free of the disease 2 and 1/2 years later following non-surgical, endoscopic treatment with radiofrequency ablation.

In the procedure, the physician can ablate, or zap, abnormal tissue within the esophagus. Called the HALO ablation system, two components are used to remove diseased tissue — one treats large, circumferential areas of the esophagus, and the other component targets focal, non-circumferential disease.

Results were published online this month in Gastrointestinal Endoscopy, a leading scientific publication for gastrointestinal physicians and researchers.

In the clinical trial, eight U.S. centers enrolled 70 patients having intestinal metaplasia, which is the earliest stage of Barrett's esophagus. Because of an elevated risk for developing esophageal cancer, patients with the disorder generally submit to a lifetime of endoscopic examinations (surveillance) to detect potential progression to more advanced stages of the disease — or cancer. The purpose of the study was to find out if this treatment could eliminate Barrett's and possibly be an alternative to surveillance.

After treatment, patients in the trial were monitored for 2 and 1/2 years through regular endoscopic examinations to confirm if all of the diseased areas were eliminated. At the final evaluation, 98.4 percent of patients had achieved a complete response to therapy and had no remaining disease.

"This study represents an important step in understanding the best way to manage patients with Barrett's esophagus at the earliest phase of the disease and demonstrates that intestinal metaplasia can be eliminated," says Dr. Fleischer He went on to emphasize two points: (1) Since the majority of patients who have intestinal metaplasia do not go on to develop esophageal cancer, most guidelines recommend surveillance for the first phase of Barrett's, and (2) Elimination of Barrett's does not eliminate acid reflux, which led to Barrett's, so it must continue to be treated. He also added that ongoing trials continue to add to the body of knowledge about the ablation technique and its potential to reduce the risk of progression of the disease.

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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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