Barrett esophagus containing low-grade dysplasia is associated with an increased risk of developing esophageal adenocarcinoma, a cancer with a rapidly increasing incidence in the western world.
Dr Nadine and colleagues investigated whether endoscopic radiofrequency ablation could decrease the rate of neoplastic progression.
Multicenter randomized clinical trial that enrolled 136 patients with a confirmed diagnosis of Barrett esophagus containing low-grade dysplasia at 9 European sites between 2007 and 2011.
Eligible patients were randomly assigned in a 1:1 ratio to either endoscopic treatment with radiofrequency ablation (ablation) or endoscopic surveillance (control).
Ablation was performed with the balloon device for circumferential ablation of the esophagus or the focal device for targeted ablation, with a maximum of 5 sessions allowed.
The researchers primary outcome was neoplastic progression to high-grade dysplasia or adenocarcinoma during a 3-year follow-up since randomization.
|Adverse events occurred in 19% of patients receiving ablation|
|Journal of the American Medical Association|
Secondary outcomes were complete eradication of dysplasia and intestinal metaplasia and adverse events.
The research team reported that 68 patients were randomized to receive ablation, and 68 to receive control.
Ablation reduced the risk of progression to high-grade dysplasia or adenocarcinoma by 25%, and the risk of progression to adenocarcinoma by 7%.
Among patients in the ablation group, complete eradication occurred in 93% for dysplasia and 88% for intestinal metaplasia compared with 28% for dysplasia, and 0% for intestinal metaplasia among patients in the control group.
Treatment-related adverse events occurred in 19% of patients receiving ablation.
The researchers found that the most common adverse event was stricture, occurring in 12% of patients receiving ablation, all resolved by endoscopic dilation.
The data and safety monitoring board recommended early termination of the trial due to superiority of ablation for the primary outcome and the potential for patient safety issues if the trial continued.
Dr Nadine's team concludes, "In this randomized trial of patients with Barrett esophagus and a confirmed diagnosis of low-grade dysplasia, radiofrequency ablation resulted in a reduced risk of neoplastic progression over 3 years of follow-up."