Successful Ablation of Barrett's Esophagus (BE) with Low Grade Dysplasia (LGD) Using Barrx Bipolar Balloon Device: Preliminary Results of the Ablation of Intestinal Metaplasia with LGD (AIM-LDG) Trial

Abstract

Successful Ablation of Barrett’s Esophagus (BE) with Low Grade Dysplasia (LGD) Using Barrx Bipolar Balloon Device: Preliminary Results of the Ablation of Intestinal Metaplasia with LGD (AIM-LDG) Trial Virender K. Sharma, Roxane McLaughlin, Patrick Dean, Giovanni De Petris, Michele M. Moirano, David E. Fleischer Aims: To evaluate the safety, tolerability & histological clearance of BE with LGD after ablation with the BARRx device. Methods: Prospective trial in patients with 2-6 cm of LGD on 2 EGD in previous 2 yrs, confirmed by 2 pathologists. The BARRx device consists of a bipolar electrode array encircling an esophageal balloon. All patients received 12 J/cm at 300W. All patients received lansoprazole 30 mg bid. Tolerability was assessed with 0-100 VAS for periand 2-hr post-procedure discomfort, & 14-day symptom diary. EGD at 1, 3, 6 mo with 4-quadrant, q 1 cm biopsies (bx) using maximum capacity forcep; interpreted by a single blinded pathologist. Outcomes were clearance of LGD & BE. Complete Response (CR) Z all bx negative & Partial Response (PR) Z 50-99% bx negative for the outcomes(LGD or IM). Patients with 3 mo CR will proceed to 6 mo EGDCbx. Patients with LGD or BE at 3 mo will be re-treated at 4 mo and undergo 6 mo EGDCbx. Results: Five of 10 planned patients (4 male, mean age 66 yrs, range 54-76, median BE 5 cm) have enrolled. Median procedure time Z 26 min (range 19-37). Ablation time Z 1 sec/3 cm treatment segment. All patients tolerated the procedure well, with low discomfort scores on the exit survey and 14-day diary (median scores !20 out of 100 for all outcomes, except sore throat, median 40/100 resolved by day 6). At 1-mo EGD, all patients had complete healing. EGD was normal in all but 1 patient (mild asymptomatic scarring at proximal edge of ablation zone). One patient had a small focus of Barrett with HGD at 1 and 3-mo that was presumably missed at enrollment (sampling error). He was excluded after 3-month follow-up and offered standard therapy. There were no ‘‘buried glands’’ in 94 follow-up bx. A single treatment resulted in 4 (80%) patients with CR of LGD, & 2 (40%) with CR of BE & 3 (60%) PR of BE (ITT analysis). Conclusion: Ablation of BE with LGD using the BARRx bipolar balloon device creates a circumferential ablation without significant complications or buried glands. The CR of LGD after a single 12 J/cm treatment with an intentional overlap is 80%. Complete ablation of BE (without LGD) was achieved in 40% while remaining 60% had only minute residual foci of BE. Patients with persistent disease will undergo a 2 treatment. The pilot data suggests that the BARRx device can safely and effectively eliminate LGD and BE. Larger trials are planned to evaluate its effectiveness in reducing the progression of LGD to HGD and/or cancer.