HALO360 Ablation Catheter Image source: Barrx Medical

Radiofrequency (RF) ablation is an effective treatment for dysplasia in people with Barrett's esophagus, a condition that can lead to deadly gastrointestinal cancer, according to a study published in the May 28 issue of the New England Journal of Medicine.

"These results show there is a substantial difference between treatment with radiofrequency ablation and a placebo or 'sham' treatment," said the study's principal investigator Nicholas J. Shaheen, MD, an associate professor at the University of North Carolina (UNC) Schools of Medicine at Chapel Hill and UNC's Gillings School of Public Health. "It's a strongly positive finding."

Barrett's esophagus is a condition in which repeated acid reflux causes the cells that normally line the esophagus to be replaced by a different type of cell, similar to those normally found in the intestines in a process called intestinal metaplasia. Barrett's itself is not a life-threatening problem, but a percentage of people with Barrett's will develop esophageal adenocarcinoma, a deadly form of cancer.

In the study, the researchers randomized 127 people to receive either radiofrequency ablation, or a simulated ‘sham' version of the procedure at one of 19 participating medical centers.

Among those with low-grade dysplasia who received radiofrequency ablation, the investigators found that 90.5 percent were free of dysplasia 12 months after treatment, compared to 22.7 percent in those who received the sham procedure. Among those with high-grade dysplasia, 81 percent who received radiofrequency ablation had complete eradication of intestinal metaplasia, compared to 19 percent in the sham group.

Shaheen and colleagues reported that patients in the ablation group had less disease progression (3.6 vs. 16.3 percent) and fewer cancers (1.2 vs. 9.3 percent).

However, patients reported having more chest pain after the ablation procedure than after the sham procedure. Also, in the ablation group, one patient had upper gastrointestinal hemorrhage, and five patients had esophageal stricture, according to the authors.

Based on their findings, Shaheen and colleagues concluded that in patients with dysplastic Barrett's esophagus, radiofrequency ablation was associated with a high rate of complete eradication of both dysplasia and intestinal metaplasia and a reduced risk of disease progression.

Funding for the study was provided by Barrx Medical, which manufactures the HALO360 radiofrequency ablation system used in the study, AstraZeneca and a grant from the National Institutes of Health (NIH).