Endoscopic eradication therapy with multifocal cryoballoon ablation for Barrett esophagus-related neoplasia: a prospective European multicenter study

Background Focal cryoballoon ablation (FCBA) is a relatively new ablation modality for the treatment of Barrett esophagus (BE)-related neoplasia. This prospective, multicenter study aimed to evaluate the efficacy and safety of FCBA for the treatment of BE. Methods In eight European Barrett expert centers, patients with a C≤2M≤5 BE segment (according to Prague classification) with dysplasia or early cancer were eligible for inclusion. Before entry, any visible lesion if present had to be removed by endoscopic resection (ER). FCBA was performed by trained endoscopists at 3-month intervals until complete eradication of BE (max. 5 sessions). After at least two FCBA sessions, add-on treatment was allowed. Post-treatment, follow-up endoscopy was scheduled at 6 months and annually thereafter. Outcomes were complete eradication of endoscopically visible BE (CE-BE), intestinal metaplasia (CE-IM), and dysplasia (CE-D), durability of treatment response and adverse events. Results 107 patients (91 males; mean age 65) with a median BE of C0M2 were included. ER at entry was performed in 65% (69/107) followed by a median of 2 FCBA treatments. Add-on treatment was performed in 40% (43/107), mainly APC for small remaining islands (38%; 41/107). CE-BE and CE-D was achieved in 94% (101/107; 95% CI 90%-98%) and CE-IM in 91% (97/107; 95% CI 85%-95%), per intention-to-treat analysis. Per-protocol analysis, CE-BE and CE-D was achieved in 100% (101/101; 95% CI 100%-100%), and CE-IM in 96% (97/101; 95% CI 92%-99%). After a median follow-up of 18 months, 96% (97/101; 95% CI 92%-99%) remained free of endoscopically visible BE. Esophageal stricture was the most common adverse event in 13% (13/101; 95% CI 6%-20%). Conclusion In expert hands, endoscopic eradication therapy with FCBA is highly effective in selected patients with BE of limited length, although the potential risk for stricture formation warrants further research