Endoscopy 2022; 54(01): 64-70
DOI: 10.1055/a-1381-7562
Innovations and brief communications

Novel cryoballoon 180° ablation system for treatment of Barrett’s esophagus-related neoplasia: a first-in-human study

1  Dept. of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands
2  Dept. of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, The Netherlands
,
Sanne N. van Munster
1  Dept. of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands
3  Dept. of Gastroenterology and Hepatology, Amsterdam University Medical Centers, The Netherlands
,
Wouter B. Nagengast
4  Dept. of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, The Netherlands
,
Roos E. Pouw
3  Dept. of Gastroenterology and Hepatology, Amsterdam University Medical Centers, The Netherlands
,
Jacques J. G. H. M. Bergman
3  Dept. of Gastroenterology and Hepatology, Amsterdam University Medical Centers, The Netherlands
,
Erik J. Schoon
5  Dept. of Gastroenterology and Hepatology, Catharina Hospital Eindhoven, The Netherlands
,
Bas L. A. M. Weusten
1  Dept. of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands
2  Dept. of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, The Netherlands
› Author Affiliations
Trial Registration: Netherlands National Trial Register (www.trialregister.nl)Registration number (trial ID): NL6495 Type of study: Prospective, single-arm, multi-center study

Abstract

Background The novel 180° cryoballoon (CbAS180) enables semicircumferential treatment over a length of 3 cm per application. This first-in-human study evaluates its feasibility, efficacy, and safety for the treatment of Barrett’s esophagus (BE) neoplasia.

Methods This multicenter study consisted of dose-finding and extension phases. Dose-finding started with the lowest dose possible (1.0 mm/s). For each dose, six patients were treated circumferentially over a 3-cm length. The dose was increased until the median BE regression was ≥ 60 % without serious adverse events (SAEs). In the extension phase, the dose was confirmed in 19 new patients. The outcomes were technical success, BE regression after one treatment, and SAEs.

Results 25 patients (median Prague C0M3) were included (6 dose-finding/19 extension). In two patients, the CbAS180 could not be applied because of unstable balloon positioning. The technical success rate was 96 % (22 /23). In the six dose-finding patients, the starting dose resulted in median BE regression of 94 % (95 % confidence interval [CI] 60 %–97 %) without SAEs and was thus considered effective. Overall median BE regression was 80 % (95 %CI 60 %–90 %).

Conclusion Single-session CbAS180 seems feasible, safe, and effective, and is a promising technique for the treatment of patients with BE neoplasia.



Publication History

Received: 30 September 2020

Accepted after revision: 19 January 2021

Publication Date:
04 March 2021 (online)

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