Aims Focal cryoballoon ablation has shown promising results for limited Barrett’s esophagus
(BE). The Cryoballoon Swipe Ablation System (CbSAS) was recently developed to treat
larger BE. The CbSAS90 (treatment of 90° over 3cm) has recently been shown to be feasible and effective.
The CbSAS180 is a new balloon catheter that directly treats half of the esophageal circumference
(180°). This first-in-human study reports on the feasibility, safety and efficacy
of CbSAS180.
Methods In this multicenter study, patients with BE (C≤3) and an indication for ablation
were included. The study consists of two phases, a dose-finding and confirmation phase.
Dose-finding started with the lowest dose possible (1.0mm/s). Per dose 6 patients
were treated circumferentially (2 CbSAS180 applications) over 3cm length. The dose was increased until the median BE regression
was ≥60% without dose-related serious adverse events (DR-SAEs). BE regression was
assessed on videos and still images by 2 independent expert endoscopists. DR-SAEs
were defined as severe pain or strictures requiring dilation. In the second phase,
the dose found in phase I will be confirmed in 19 new patients. Pain (0-10) and dysphagia
(0-4) were evaluated during follow-up. Outcome parameters were technical success,
DR-SAEs and BE regression.
Results Six patients were included with a median Prague score of C0M2.5 and 50% previous
endoscopic resections. The procedure was technically successful in all patients. Median
ablation time was 6 minutes. The starting dose resulted in median 94% BE regression
(range 60-99.5) without DR-SAEs. Median pain scores (IQR) were 2.5(2-5), 2.5(0-4),
0(0-1), 0(0-0) at days 0,1,7&30 respectively, and median dysphagia scores (IQR) 0.5(0-1)
at day 1 and 0(0-0) for days 0,7&30.
Conclusions CbSAS180 is feasible and treatment with a dose of 1.0mm/s resulted in 94% BE regression. The
safety and efficacy of this dose will be confirmed in 19 new patients.
