Trials find radiofrequency ablation is durable after 2 years, compares favorably with endoscopic resection for advanced disease and reduces the risk for cancer progression
SUNNYVALE, Calif., June 3 /PRNewswire/ -- Results from a number of clinical trials were presented during the Digestive Disease Week (DDW) in Chicago, revealing new outcomes data related to endoscopic radiofrequency ablation using the HALO ablation system for eradicating a pre-cancerous esophageal condition known as Barrett's esophagus. Among them, reports included durability outcomes from a randomized sham-controlled trial, safety and efficacy outcomes from a large U.S. registry of 429 patients, a randomized trial comparing ablation to endoscopic resection, and the largest European series to date in patients with high-grade dysplasia and early cancer.
As the DDW meeting commenced, the New England Journal of Medicine published a landmark paper entitled, "Radiofrequency Ablation for Barrett's Esophagus Containing Dysplasia." This is a U.S. randomized sham-controlled trial demonstrating high rates of complete eradication of Barrett's and dysplasia in the ablation group as compared to control, as well as a significant reduction in cancer progression. At DDW, researchers presented new data from this now published trial, showing that the ablation effect achieved at 1 year follow-up was highly durable at the 2-year follow-up.
In the largest patient series to date, "Radiofrequency Ablation of Barrett's Esophagus: Outcomes of 429 Patients from a Multi-center Community Practice Registry," U.S. investigators reported a low stricture risk (about 1 and no serious adverse events. After an average of 2 ablation procedures using the HALO ablation system and 20-month follow-up, 77% of patients were cured of their Barrett's disease. For those patients that had baseline evidence of dysplasia, 100% had complete eradication of all signs of dysplasia. These data comport with published data from predominantly tertiary referral centers.
A European multi-center randomized trial included 47 patients with Barrett's containing dysplasia and early cancer that were randomized to receive either endoscopic resection or radiofrequency ablation with the HALO ablation system. While both interventions had very high complete eradication rates (95-100, endoscopic resection was associated with a significantly higher risk of complications. Based on these results, investigators concluded that the optimal approach is to focally resect visible lesions followed by radiofrequency ablation for complete eradication of the remaining Barrett's tissue. In the largest European series reported to date, "Radiofrequency Ablation for Eradication of Barrett's Esophagus Containing High-Grade Dysplasia or Early Cancer: A Prospective Series of 73 Patients," researchers combined a baseline focal endoscopic resection for disease staging, and then applied serial RFA with the HALO ablation system. A complete response was achieved in 95% of patients without occurrence of serious adverse events.
"Barrett's esophagus places a patient at a significantly higher risk for developing esophageal adenocarcinoma," commented David S. Utley, M.D., chief medical officer for BARRX Medical. "Researchers at this national meeting are reporting the results of a number of well-designed clinical trials using endoscopic radiofrequency ablation to completely eradicate the Barrett's tissue. Each unique study design offers new data that continues to establish an evidence-based role for radiofrequency ablation in managing this disease state."