Digestive Diseases News
Fall 2009

Radiofrequency Ablation Effectively Treats Barrett’s Esophagus

Radiofrequency ablation (RFA), a technique involving the use of endoscopically controlled electric probes, effectively removes precancerous cells of the esophagus, according to a study funded by BÂRRX Medical with partial support from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The multicenter trial showed that more than 75 percent of participants with Barrett’s esophagus who were treated with RFA were free of precancerous cells after 1 year, compared with 2.3 percent of controls who received a sham procedure.

“Our data show that most patients who were treated with radiofrequency ablation had complete eradication of intestinal metaplasia and dysplasia and a decreased risk of disease progression at 12 months,” wrote Nicholas J. Shaheen, M.D., M.P.H., director of the Center for Esophageal Diseases and Swallowing, University of North Carolina, Chapel Hill, and co-authors in a report that appeared in the May 28 issue of The New England Journal of Medicine.

Intestinal metaplasia occurs when normal esophageal epithelial cells—the cells that line the esophagus—are replaced with cells similar to those of the large and small intestines. Dysplasia refers to the presence of precancerous cells.

Increasing Problem

The incidence of esophageal carcinoma, a cancer of the esophagus that is difficult to detect and treat, has increased dramatically during the past 30 years. Scientists believe the increase is tied to rising rates of gastroesophageal reflux disease (GERD), a condition that occurs when stomach contents rise into the esophagus. Some gastroesophageal reflux (GER) is normal, but when it occurs too often, it can cause intestinal metaplasia, also known as Barrett’s tissue. The resulting condition, Barrett’s esophagus, can lead to dysplasia and esophageal cancer. The reason for the rise in GERD is unclear; however, risk factors include being obese, Caucasian, male, and older than 40.

A small fraction of people with Barrett’s esophagus develop esophageal carcinoma. Risk corresponds to the degree of dysplasia, which is graded through biopsy of endoscopically obtained esophageal tissue.

Standard care for people with Barrett’s esophagus involves monitoring dysplasia through endoscopy and biopsy of esophageal tissue. If high-grade dysplasia is detected, Barrett’s tissue is often removed using one of several therapies, including surgical removal of the affected section of the esophagus, called esophagectomy, and photodynamic light therapy, which uses lasers to destroy cells that are made light sensitive with drugs called photosensitizers.

Because most people with Barrett’s esophagus will never develop esophageal cancer, debate continues about when patients should receive treatment and which treatment is safest and most effective.

“Despite the large number of patients with Barrett’s esophagus and the remarkable increase in the incidence of esophageal adenocarcinoma in the past 30 years,” wrote Shaheen and colleagues, “the optimal management strategy for dysplastic Barrett’s esophagus has not been defined.”

RFA

RFA uses an electrode to heat and kill dysplastic cells. Used for years to treat other conditions, RFA has only recently been adapted to treat Barrett’s esophagus.

Shaheen and colleagues enrolled 127 patients with either high- or low-grade dysplasia of the esophagus in a study and randomized them to either an ablation group that received up to four ablation sessions or a control group that received a sham procedure. During the study, all participants took the drug esomeprazole—a drug used to control GER symptoms.

Devices used to perform the ablation included a specially designed endoscopic balloon, wrapped with an electrode array, and a focal RFA device. Both devices are made by BÂRRX Medical. The balloon ablation device is designed to treat large sections of affected esophagus, whereas the focal ablation device is designed to treat smaller patches of tissue.

To monitor dysplasia, biopsies were conducted at several time points over a period of 1 year. Biopsied tissues were collected from multiple areas in the esophagus. Pathologists judged dysplasia using standardized criteria.

Important Implications

After 1 year, among participants in the ablation group with initially low-grade dysplasia, 90.5 percent were free of dysplasia, compared with 22.7 percent of controls. Among those in the ablation group with high-grade dysplasia, 81 percent were free of dysplasia, compared with 19 percent of controls. Intestinal metaplasia was absent in 77.4 percent of participants who received ablation, regardless of dysplasia grade, compared with 2.3 percent of all controls. Controls were more likely to experience disease progression, as measured by dysplasia, and had a higher rate of esophageal cancer development. The occurrence of adverse events among participants in the ablation and control groups was similar.

“This study has important implications for the treatment of high-grade dysplasia in patients with Barrett’s esophagus,” wrote Jacques Bergman, M.D., Ph.D., Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands, in a companion editorial. Based on the results of this study, according to Bergman, RFA is more effective than photodynamic light therapy and much safer than esophagectomy.

Despite positive results that RFA is safe and effective, a randomized comparison of endoscopic surveillance and RFA is needed to define factors that influence treatment response and to determine if RFA is durable and improves patients’ quality of life, according to Bergman. “Such a study might truly revolutionize the management of this condition and answer the question as to whether radiofrequency ablation is great just for some or justified for many.”

The NIDDK has information about Barrett’s esophagus and GERD. Visit www.digestive.niddk.nih.gov for free fact sheets and easy-to-read booklets about these and other digestive diseases.

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NIH Publication No. 10–4552
October 2009