Emory gastrointestinal surgeons were the first in Georgia, and among the first in the nation, to successfully treat a patient suffering from Barrett's esophagus with the FDA-approved Halo360 system, a device that uses bursts of radiofrequency energy to remove abnormal tissue without damaging healthy tissue.
Barrett's esophagus is a precancerous condition caused when chronic gastroesophageal reflux disease (GERD) damages the lining of the esophagus. It affects an estimated two million adults in the United States, and 86,000 new cases are diagnosed each year. Left untreated, Barrett's esophagus can lead to a dangerous type of cancer called esophageal adenocarcinoma, which has a five-year patient survival rate of just 16 percent.
Traditionally, treatment options have been limited, and many times a "watch and wait" approach was the best option available. "The limitations of technology have prevented many Barrett's patients from receiving treatment before their disease becomes a serious and potentially life-threatening problem," says C. Daniel Smith, MD, professor of surgery and chief of the Division of General and GI Surgery, Emory University School of Medicine.
Traditional ablation techniques can not uniformly treat the esophageal lining, resulting in either excessively deep ablation that damages healthy tissue or shallow treatment that only allows the Barrett's cells to be covered up by new tissue growth. In addition, many of the ablation devices require very high operator skill which can lead to variability in therapy.
The Halo360 system is an endoscopic tool that provides uniform and controlled ablative therapy at a consistent depth, which can remove Barrett's cells and allow the re-growth of normal cells. It also provides preset sizing and fixed energy capabilities, making it possible for physicians to effectively treat patients without injuring healthy underlying tissue.
"The ability to provide a controlled amount of ablative therapy to diseased tissue significantly reduces the risk of complications normally associated with other forms of ablation therapy," says Dr. Smith.
Dr. Smith and his team were instrumental in the progress of the Halo360 system, leading a clinical trial to determine the optimal treatment parameters for the ablation of high-grade abnormal tissue cells found in Barrett's esophagus.
Last month at Digestive Disease Week, the world's largest meeting for gastro-intestinal professionals, Dr. Smith presented the results of this research before GI specialists from around the globe. This research found that the complete ablation of esophageal high-grade dysplasia, or abnormal tissue cells that are susceptible to developing into a malignant state, is possible without causing injury to the healthy underlying tissue.
"We found this system to be an effective treatment option for patients. With this new option, patients can be treated on an outpatient basis with very minimal side effects," notes Dr. Smith.
The procedure, which in clinical studies had a median procedure time of 26 minutes, is performed without incisions using conscious sedation in an out-patient setting. First, a physician uses a Halo360 sizing balloon catheter to dilate the esophagus and determine its inner diameter. A correctly sized ablation catheter is then inflated within the diseased area of the esophagus.
Controlled delivery of energy avoids injury to normal, healthy underlying tissues. According to trial results, new healthy tissue replaces the ablated Barrett's tissue in three to four weeks for most patients. Minor discomfort, which may be experienced by some patients, has been managed in the trials with medication. Following ablation therapy, patients resume acid suppression therapy.
The device was cleared by the U.S. Food and Drug Administration in 2001 and became commercially available in January 2005.