Progression of disease, which can precede cancer, was rare in patients who underwent RFA treatment, and there was no procedure- or cancer-related mortality.
"This study reports the longest duration of follow-up of patients undergoing radiofrequency ablation for pre-cancerous Barrett's esophagus," said Nicholas J. Shaheen, MD, MPH, of the University of North Carolina at Chapel Hill and lead author of this study. "Because those with dysplastic Barrett's esophagus are at highest risk for progression to cancer, such data are essential to understanding the value of ablative therapy in the setting of Barrett's esophagus. These patients should discuss with their physician whether such treatment might be appropriate for them."
In patients with Barrett's esophagus, the normal cells lining the esophagus are replaced with tissue that is similar to the lining of the intestine. A minority of people with Barrett's esophagus develop a rare, but often deadly, type of cancer of the esophagus. If cancer is to develop, precancerous changes — also called dysplasia — are often found in the Barrett's esophagus. The traditional treatment for such patients is surgical removal of the esophagus. While effective, this major surgery has a significant complication rate, and some mortality associated with it.
RFA is a minimally invasive treatment alternative for dysplastic Barrett's esophagus in which the inner lining of the esophagus, which contains the precancerous cells, is destroyed by applying high radiofrequency waves to it, causing a thermal injury or "burn." When these precancerous cells are destroyed, normal tissue usually regenerates in its place.
Study results demonstrated that more than 90 percent of the 119 patients treated with RFA demonstrated complete eradication of abnormal pre-cancerous cells and intestinal metaplasia (cells similar to those lining the intestine) at an average follow-up of greater than three years.
Of the 56 subjects who had reached three years of follow-up in the study, dysplasia was cleared in 55 subjects (98 percent); intestinal metaplasia was cleared in 51 of 56 subjects (91 percent). While re-treatment with RFA was allowed as part of the study protocol for any patient with recurrent Barrett's, more than 85 percent of patients stayed free of dysplasia, and more than 75 percent stayed free of intestinal metaplasia without any treatments after the first year of the study.
On average, three to four outpatient RFA endoscopic procedures are required to completely remove all the precancerous tissues. Follow-up of patients after three years demonstrated that a high percentage of subjects with both low-grade and high-grade dysplasia remained free of dysplasia and intestinal metaplasia after treatment. Most subjects with recurrence of disease could again attain complete elimination of intestinal metaplasia with further treatment.
"The information from this study suggests that radiofrequency ablation, a treatment that is available in multiple centers throughout the U.S., results in the removal of precancerous cells from the esophagus, and that this removal is durable, at least out to the three-year time horizon of the study. This patient population will continue to be followed to better define the long-term outcomes with this treatment," added Dr. Shaheen.
In March 2011, the AGA released the "American Gastroenterological Association Medical Position Statement on the Management of Barrett's Esophagus
" recommending the endoscopic removal of pre-cancerous cells in patients with confirmed, high-risk Barrett's esophagus rather than surveillance. The position statement was published in Gastroenterology.