Multifocal cryoballoon ablation achieves high eradication rates in Barrett esophagus with dysplasia
This prospective European multicenter study evaluated endoscopic eradication therapy with multifocal cryoballoon ablation (FCBA) in 107 patients with Barrett esophagus (BE) segments defined by Prague classification C≤2M≤5, who had dysplasia or early cancer. The intervention involved FCBA administered at 3-month intervals until complete eradication of BE, with a maximum of five sessions, and add-on treatment was allowed after at least two FCBA sessions. The primary outcome was complete eradication of endoscopically visible BE (CE-BE), intestinal metaplasia (CE-IM), and dysplasia (CE-D), with secondary outcomes including durability of treatment response and adverse events; follow-up occurred at 6 months and annually thereafter, with a median of 18 months.
Main results showed that on intention-to-treat analysis, CE-BE and CE-D were achieved in 94% (101/107; 95%CI 90%-98%), and CE-IM in 91% (97/107; 95%CI 85%-95%). Per-protocol analysis (101 patients) indicated 100% (101/101; 95%CI 100%-100%) for CE-BE and CE-D, and 96% (97/101; 95%CI 92%-99%) for CE-IM. At median 18-month follow-up, 96% (97/101; 95%CI 92%-99%) remained free of endoscopically visible BE. Safety data reported esophageal stricture in 13% (13/101; 95%CI 6%-20%), but serious adverse events, discontinuations, and tolerability were not reported.
Key limitations include the potential risk for stricture formation, which warrants further research, and funding or conflicts of interest were not reported. The study suggests FCBA was highly effective in selected patients with BE of limited length, but clinicians should consider the stricture risk and the need for more data on long-term outcomes and safety in broader populations.