A novel cryoballoon ablation system for eradication of dysplastic Barrett’s esophagus: a first-in-human feasibility study

Sanne Noortje van Munster; Anouk Overwater; Mihaela G. M. Raicu; Kees C. A. Seldenrijk; Wouter B. Nagengast; Erik J. Schoon; Jacques J. G. H. M. Bergman; Bas L. A. M. Weusten

doi:10.1055/a-1024-3967

Endoscopy, Table of Contents

Endoscopy 2020; 52(03): 193-201
DOI: 10.1055/a-1024-3967

Original article

A novel cryoballoon ablation system for eradication of dysplastic Barrett’s esophagus: a first-in-human feasibility study

Sanne Noortje van Munster‡^*

¹Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands

²Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, the Netherlands

,

Anouk Overwater‡^*

¹Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands

³Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, the Netherlands

,

Mihaela G. M. Raicu

⁴Pathology DNA, St. Antonius Hospital, Nieuwegein, the Netherlands

,

Kees C. A. Seldenrijk

⁴Pathology DNA, St. Antonius Hospital, Nieuwegein, the Netherlands

,

Wouter B. Nagengast

⁵Department of Gastroenterology and Hepatology, University Medical Center Groningen, the Netherlands

,

Erik J. Schoon

⁶Department of Gastroenterology and Hepatology, Catharina Hospital Eindhoven, the Netherlands

,

Jacques J. G. H. M. Bergman

²Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, the Netherlands

,

Bas L. A. M. Weusten

¹Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands

³Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, the Netherlands

› Author Affiliations

Abstract

Background Endoscopic cryoablation for Barrett’s esophagus (BE) might offer advantages over heat-based ablation. Focal cryoballoon ablation has been promising for short-segment BE, whereas the novel 90°-swipe cryoballoon ablation system (CbSAS⁹⁰) ablates larger areas in a single step (90° over 3 cm). The system allows for dose adjustment. CbSAS⁹⁰ has been feasible and safe in animal and pre-esophagectomy studies. This is the first clinical study to assess feasibility, safety, and efficacy of CbSAS⁹⁰ for eradication of dysplastic BE.

Methods In this prospective study in dysplastic BE patients, dose finding started with semi-circumferential treatment at 0.8 mm/s (dose 1). The dose was escalated by reducing speed by 0.1 mm/s in six patients until BE surface regression was ≥ 80 % without complications (“effective dose”). The effective dose was subsequently confirmed with circumferential treatment in 12 new patients. Post-procedural pain (0 – 10) and dysphagia (0 – 4) were evaluated. Outcomes were feasibility, safety, and BE surface regression.

Results 25 patients were included, with technically successful treatment in 92 % (95 %CI 73 % – 99 %). Median (95 %CI) BE surface regression was 78 % (50 % – 85 %) for dose 1 and 85 % (55 % – 95 %) for dose 2 (0.7 mm/s), which was defined as the effective dose. Circumferential treatment resulted in 93 % (88 % – 96 %) regression. Two of 12 patients with circumferential treatment developed strictures that required dilation. Median pain and dysphagia scores were low (0 – 3 and 0, respectively).

Conclusions CbSAS⁹⁰ was feasible and effective for ablating larger BE areas. The optimal dose for circumferential treatment that balances safety and efficacy requires further evaluation.

Full Text

References

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Supplementary Material

Supplementary material