Introduction
Focal cryoballoon ablation (FCBA) is a relatively new ablation modality for the treatment of Barrett’s esophagus (BE) related neoplasia. This prospective, European multicenter study (Euro-Coldplay, NTR NL7253) aimed to evaluate the efficacy and safety of FCBA for the treatment of limited BE.
Aims & Methods
In eight European Barrett referral centers, patients with C≤2M≤5 BE with an indication for ablation therapy were eligible for inclusion. Before entry, any visible lesion had to be removed by endoscopic resection (max. 2cm in length and 50% of circumference). FCBA was performed by experienced and trained endoscopists at 3 month intervals until complete endoscopic eradication of BE (max. 5 sessions). During every session, the esophagogastric junction was treated circumferentially followed by all visible BE using side-by-side ablations with a dose of 8 seconds per ablation. After at least two FCBA sessions, add-on treatment was allowed with either argon plasma coagulation (APC) for BE lesions of <5mm (max. 2 sessions) or a single endoscopic mucosal resection for lesions of >5mm. Outcomes included complete eradication of intestinal metaplasia (CE-IM) and dysplasia (CE-D), and adverse event rate.
Results
107 patients (91 males; mean age 65) with a median BE length of C0M2 were included, containing low-grade dysplasia (32%), high-grade dysplasia (32%) or early cancer (39%) as worst baseline histology. Currently, 5/107 patients are still under treatment and therefore excluded from further analysis. Of the remaining patients, 97 (97/102; 95%) patients have finished the treatment phase per protocol, while four (4/102; 4%) patients left the study prematurely. Only one (1/102; 1%) patient could not be treated with FCBA due to a device malfunction requiring a switch to radiofrequency ablation. Overall, 65/102 (64%) patients underwent endoscopic resection at entry followed by a median of 2 (IQR 2-2) FCBA treatments with a median of 7 (IQR 5-9) ablations per treatment session. During the treatment phase, 3/102 (3%) patients developed a new visible, neoplastic lesion amenable for endoscopic resection (high-grade dysplasia n = 2, low-risk T1 cancer n = 1). Add-on treatment after at least two FCBA sessions was performed in 38/102 (37%) patients, of whom the most were treated with APC for small remaining Barrett islands (37/38; 97%). CE-D was achieved in 95% (97/102) and CE-IM in 91% (93/102), per intention-to-treat analysis. Per-protocol analysis, CE-D and CE-IM were achieved in 100% (97/97) and 96% (93/97), respectively. Esophageal stricture was the most common adverse event in 13/102 (13%) patients, which resolved after a median of 2 (IQR 1-4) dilations. Only three (3/102; 3%) patients suffered a severe stricture requiring >3 dilations. No perforation or bleeding were observed, while buried BE glands were seen in 1/102 (1%).
Conclusion
In expert hands, endoscopic eradication therapy with FCBA seems to be highly effective with an acceptable safety profile for patients with limited BE. Long-term follow-up is warranted to evaluate the durability of the treatment response.
Disclosure
C.N. Frederiks have received speaker's fee and reimbursement of study-related travel costs from Pentax Medical. A. Overwater has received reimbursement of study-related travel costs from Pentax Medical. J.J.G.H.M. Bergman is a consultant for Medtronic, Cook Medical, and Boston Scientific, and has received research funding from Pentax Medical, C2 Therapeutics, Medtronic, Aqua Medical, Olympus Endoscopy, and Fuji-film. R.E. Pouw is a consultant for MicroTech, and has received speaker’s fee from Medtronic. R. Bisschops is a consultant for Pentax Medical, Medtronic, and Erbe Medical, and has received research funding and speaker’s fees from Pentax Medical, Medtronic, and Erbe Medical. T. Beyna is consultant for Medtronic, Erbe Medical, Microtech Endoscopy, Olympus Endoscopy, and Boston Scientific. B.L.A.M. Weusten has received research funding from Pentax Medical, C2 Therapeutics, and Aqua Medical. The remaining authors declare to have no disclosures relevant to this manuscript.
