Efficacy and safety of the cryoballoon 180 ablation system for the treatment of dysplastic Barrett’s esophagus: preliminary results from a prospective Dutch multicenter study

Aims Cryoballoon ablation is a relatively new method which can be used for the eradication of dysplastic Barrett’s esophagus (BE). While the focal cryoballoon ablation system has shown promising results for limited BE, the cryoballoon¹⁸⁰ ablation (CBAS¹⁸⁰) system is developed to ablate the esophagus semi-circumferential over 3cm length which enables treatment of larger BE segments. Although a prior first-in-human study demonstrated that CBAS¹⁸⁰ treatment was feasible and effective, there was also room to optimize the safety profile by reducing the dose. Therefore, in the current study, we investigated a lower dose of the CBAS¹⁸⁰ system in patients with dysplastic BE.

Methods Patients with ablation naïve BE with a length of C≤3 and M≥1 were enrolled in three Dutch Barrett expert centers. Treatment consisted of a full circumferential ablation using two semi-circumferential ablations of 3cm in length with the CBAS¹⁸⁰ system at a dose of 1.2 mm/sec. Patients received additional follow-up phone calls at days 1, 7 and 30 post-treatment and underwent a follow-up endoscopy after 3 months. Outcomes included the technical success rate, BE regression percentage at follow-up (scored by the treating endoscopist), adverse events, post-procedural pain (scored on a scale of 0-10) and dysphagia (scored on a validated scale of 0-4).

Results Twenty-five patients (80% male; mean age 67) with a median BE length of C0M2 were included. In two patients treatment was technically unsuccessful due to unstable positioning of the balloon (n=1) and device malfunction (n=1) resulting in a technical success rate of 92% (23/25; 95% CI 74-99%). So far, 16/24 patients completed follow-up endoscopy. Median BE regression was 95% (p25-p75 80-99%; 95% CI 70-99%). One patient had post-procedural bleeding after 11 and 22 days (1/25; 4%; 95% CI 1-20%) which required two hospital admissions (duration 3 and 2 days) and one re-endoscopy without intervention. No esophageal strictures or other adverse events occurred. The procedure was generally well tolerated with low post-procedural pain and dysphagia scores. Median post-procedural pain scores (in 23 patients) at discharge, days 1, 7, and 30 were 1 (p25-p75 0-4), 1 (p25-p75 0-2), 0 (p25-p75 0-0), and 0 (p25-p75 0-0). Median dysphagia scores were 0 at all follow-up points (p25-p75 0-1).

Conclusions Drawing from these preliminary results, circumferential CBAS¹⁸⁰ ablation at 1.2 mm/sec emerges as an effective and safe procedure in the hands of experts. Before embracing widespread adoption of this technique in all BE lengths, further avenues for exploration should encompass the assessment of multiple ablations stacked on top of each other in larger segments and the validation of outcomes in a substantial patient cohort.

Publication History

Article published online:
15 April 2024