RESUMEN
BACKGROUND: Endoscopic cryoablation for Barrett's esophagus (BE) might offer advantages over heat-based ablation. Focal cryoballoon ablation has been promising for short-segment BE, whereas the novel 90°-swipe cryoballoon ablation system (CbSAS90) ablates larger areas in a single step (90° over 3âcm). The system allows for dose adjustment. CbSAS90 has been feasible and safe in animal and pre-esophagectomy studies. This is the first clinical study to assess feasibility, safety, and efficacy of CbSAS90 for eradication of dysplastic BE. METHODS: In this prospective study in dysplastic BE patients, dose finding started with semi-circumferential treatment at 0.8âmm/s (dose 1). The dose was escalated by reducing speed by 0.1âmm/s in six patients until BE surface regression was ≥â80â% without complications ("effective dose"). The effective dose was subsequently confirmed with circumferential treatment in 12 new patients. Post-procedural pain (0â-â10) and dysphagia (0â-â4) were evaluated. Outcomes were feasibility, safety, and BE surface regression. RESULTS: 25 patients were included, with technically successful treatment in 92â% (95â%CI 73â%â-â99â%). Median (95â%CI) BE surface regression was 78â% (50â%â-â85â%) for dose 1 and 85â% (55â%â-â95â%) for dose 2 (0.7âmm/s), which was defined as the effective dose. Circumferential treatment resulted in 93â% (88â%â-â96â%) regression. Two of 12 patients with circumferential treatment developed strictures that required dilation. Median pain and dysphagia scores were low (0â-â3 and 0, respectively). CONCLUSIONS: CbSAS90 was feasible and effective for ablating larger BE areas. The optimal dose for circumferential treatment that balances safety and efficacy requires further evaluation.