Endoscopy 2020; 52(S 01): S115
DOI: 10.1055/s-0040-1704356
ESGE Days 2020 oral presentations
Saturday, April 25, 2020 08:30 – 10:30 Esophageal High-tech: Newtreatment modalities for the esophagus Liffey Meeting Room 2
© Georg Thieme Verlag KG Stuttgart · New York

FIRST-IN-HUMAN EXPERIENCE OF THE NOVEL CRYOBALLOON SWIPE 180 ABLATION SYSTEM IN PATIENTS WITH DYSPLASTIC BARRETT’S ESOPHAGUS

A Overwater
1   St. Antonius Hospital, Department of Gastroenterology and Hepatology, Nieuwegein, Netherlands
2   University Medical Center Utrecht, Department of Gastroenterology and Hepatology, Utrecht, Netherlands
,
SN van Munster
1   St. Antonius Hospital, Department of Gastroenterology and Hepatology, Nieuwegein, Netherlands
3   Amsterdam UMC, Department of Gastroenterology and Hepatology, Amsterdam, Netherlands
,
G Mihaela Raicu
4   St. Antonius Hospital, Pathology DNA, Nieuwegein, Netherlands
,
CA Seldenrijk
4   St. Antonius Hospital, Pathology DNA, Nieuwegein, Netherlands
,
JJGHM Bergman
3   Amsterdam UMC, Department of Gastroenterology and Hepatology, Amsterdam, Netherlands
,
WB Nagengast
5   University Medical Center Groningen, Department of Gastroenterology and Hepatology, Groningen, Netherlands
,
EJ Schoon
6   Catharina Hospital, Department of Gastroenterology and Hepatology, Eindhoven, Netherlands
,
RE Pouw
3   Amsterdam UMC, Department of Gastroenterology and Hepatology, Amsterdam, Netherlands
,
BLAM Weusten
1   St. Antonius Hospital, Department of Gastroenterology and Hepatology, Nieuwegein, Netherlands
2   University Medical Center Utrecht, Department of Gastroenterology and Hepatology, Utrecht, Netherlands
› Author Affiliations
Further Information

Publication History

Publication Date:
23 April 2020 (online)

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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.