Background BÂRRX Medical has developed a promising new balloon-based electrode device for ablation of Barrett's esophagus (BE) using rapid circumferential radiofrequency energy.
Aims To assess the safety, tolerability, and response associated with BÂRRX ablation of short-segment (SSBE) versus long-segment Barrett's esophagus (LSBE).
Methods Prospective trial in patients followed at Harbor-UCLA Medical Center with non-dysplastic intestinal metaplasia confirmed by biopsy on prior EGD within the last year. Patients are assigned to either the SSBE (< 3 cm) or LSBE (≥ 3 cm) group. Patients receive two ablations at 10 J/cm2 on their initial treatment. Tolerability during and after the procedure is recorded using a 7-day patient diary assessing symptoms on a 10-point scale. All patients receive lansoprazole 30 mg twice daily for 1 month, then 30 mg daily. During the follow-up period, patients return at 3 and 12 months post-treatment for EGD with biopsies collected in four quadrants along every 1 cm from the original BE. Any patients with all biopsies negative are deemed to have complete response (CR) and return at 12 months for EGD with biopsies. Patients with intestinal metaplasia present on any biopsy or incomplete response (IR) will return at 6 months for repeat treatment and follow-up at 12 months for EGD with biopsies. End points included clearance of intestinal metaplasia (CR), persistent IR after two treatments, any complications, or loss to follow-up.
Results 7 of 50 planned patients (4 male, mean age 53.4, 5 with LSBE, mean length 5.7 cm, range 2-10 cm) have been enrolled and treated. One patient refused follow-up EGD and dropped out of the study. Three-month follow-up EGD is pending for two patients. Among the four patients (1 SSBE and 3 LSBE) who have already returned for 3-month follow-up EGD, none had endoscopic evidence of residual BE, except for one patient with LSBE (5 cm). Only the patient with SSBE (2 cm) had CR, while all three of the patients with LSBE had IR. The percentage of negative biopsies at 3 months after one treatment was 100% for the SSBE group and 61% for the LSBE group, with a mean of 71% for all four patients. Among all seven patients enrolled, the procedure was better tolerated by the patients with SSBE (mean 2/10 symptom score) versus patients with LSBE (mean 7/10 symptom score). The most frequently reported post-procedure symptoms were odynophagia and nausea. There were no strictures, perforations, or other serious complications.
Conclusions Preliminary data suggest that BÂRRX ablation is safe, well tolerated, and effective at clearing SSBE (< 3 cm). Given the high percentage of intestinal metaplasia cleared in the LSBE (61%), we expect significant rates of CR after these patients return at 6 months for repeat BÂRRX ablation.
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