Introduction
Cryoballoon Focal Ablation (CbFA; C2 Merit Medical) is a well-tolerated and effective endoscopic eradication therapy (EET) for Barrett’s esophagus (BE) with early neoplasia. Prior experience has largely been limited to BE segments of ≤C2M5, with few long-term durability data, and earlier studies using a 10-second (s) dose per ablation1. We report outcomes from a prospective UK multicentre registry using a refined approach of 8s per ablation with adjunct mucosal protective medication, adjunct argon plasma coagulation (APC) and including longer BE segments.
Aims & Methods
Consecutive patients from three UK tertiary centres were prospectively enrolled. Inclusion criteria were BE ≤C5M5 with an indication for ablation therapy, such as BE with early neoplasia (BE-D: low-grade dysplasia (LGD), high-grade dysplasia (HGD), intramucosal adenocarcinoma) without a visible lesion or residual BE following endoscopic resection of early neoplasia. CbFA was repeated at 3-monthly intervals until eradication or a maximum of five sessions, using a focal catheter with an 8 second dose per application. In between each treatment, patients received high-dose proton pump inhibitor twice daily and 14 days of sucralfate (2 g, three times daily). Adjunct APC was permitted after two CbFA sessions for residual islands <5 mm. Post treatment surveillance and biopsies followed ESGE guidance. Primary endpoints were histologically confirmed eradication of intestinal metaplasia (CE-IM), and dysplasia (CE-D) at the end of treatment. Secondary outcomes included number of ablation sessions, adverse events, device malfunction, and stricture rate.
Results
From January 2020 to November 2025, 67 patients were recruited (80.6% male; mean age 71), and underwent 138 CbFA sessions. Median pre-ablation BE length was C0M2 (maximum C5M5). Worst baseline histology was LGD in 41.8%, HGD in 31.3%, early cancer in 19.4%, and intestinal metaplasia in 7.5% (including RFA-refractory). Most patients (92.5%) were ablation treatment-naïve; 7.5% had RFA-refractory BE. Among treatment-naïve patients, 43 underwent prior endoscopic resection (39 EMR, 4 ESD).
In those patients completing CbFA treatment to date (n=22), CE-D was achieved in 100% and CE-IM 90.9%, after a median of two CbFA sessions, with 31.8% receiving adjunct APC. No device malfunctions or intraprocedural adverse events occurred. Strictures developed in 9% and resolved with balloon dilatation. Durability data were available for 10 patients (mean follow-up 31.3 months, range 14.2–53.2), with CE-D 100% and CE-IM 90.0%.
Conclusion
Interim real-world registry results, including medium-term durability, align with the larger Euro-Coldplay study2, supporting CbFA as a safe and effective EET option for BE-D in segments up to ≤C5M5, with a lower stricture rate using our refinement approach. Ongoing enrolment will further define long-term efficacy and safety in routine UK practice.
References
1. Frederiks CN, Overwater A, Alvarez Herrero L, Alkhalaf A, Schenk E, Repici A, Bergman JJGHM, Pouw RE, Bisschops R, Haidry RJ, Beyna T, Neuhaus H, Weusten BLAM. Comparison of focal cryoballoon ablation with 10- and 8-second doses for treatment of Barrett's esophagus-related neoplasia: results from a prospective European multicenter study (with video). Gastrointest Endosc. 2022 Nov;96(5):743-751.e4. doi: 10.1016/j.gie.2022.06.017. Epub 2022 Jun 18. PMID: 35724692.
2. Frederiks CN, Overwater A, Beyna T, Neuhaus H, Bisschops R, Pouw RE, Bergman JJGHM, Barret M, Maselli R, Sehgal V, Haidry RJ, Weusten BLAM. Endoscopic eradication therapy with multifocal cryoballoon ablation for Barrett esophagus-related neoplasia: a prospective European multicenter study. Endoscopy. 2025 Nov 19. doi: 10.1055/a-2710-6551. Epub ahead of print. PMID: 41005363.
Disclosure
RK received medical consultancy fees from Odin Vision (Olympus)