Abstract

Purpose: To evaluate the safety, tolerability & histological clearance of HGD & BE after RF ablation in patients with BE & HGD. Methods: Patients with biopsy-proven HGD on 2 EGD & confirmed by 2 independent pathologists without evidence of advanced disease on EUS or chest CT who refused esophagectomy or PDT were offered RF ablation for their HGD. The BARRX System was used for all treatments, which includes an esophageal balloon covered by radial RF electrodes. All patients received treatment at 300 W and 12 J/cm2. During a treatment session, ablation was delivered at least twice to the entire length of BE (intentional overlap). All patients received PPI bid post-ablation. Patients had their standard of care EGD with 4-quadrant, q 1 cm biopsies at 1, 3 & 6 mo post-ablation from the treated segment. Biopsies were interpreted by a GI pathologist. The primary endpoint was clearance of HGD & secondary endpoint was clearance of BE. Complete Response (CR) = all biopsies negative for the outcome (HGD or IM) at a given time interval. Results: Six patients with HGD treated; 2–3x intentional overlap until there was no endoscopic visible Barrett. One self limiting UGI bleed; otherwise all patients tolerated the procedure well without any complications. At this time, 4 of the 6 patients have no evidence of HGD after 1 or 2 treatments. There are no buried glands. Conclusions: Use of this ablation device creates a rapid circumferential ablation of BE with HGD without need for a photosensitizing agent and without significant complications. The CR of HGD after a 1 or 2 treatments with intentional overlap is 100% (4 out of 6 patients cleared of HGD), and the remaining 2 patients are pending initial follow-up.Table: Ablation Outcomes

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