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Open Access
CC BY 4.0 · Endoscopy
DOI: 10.1055/a-2710-6551
Original article

Endoscopic eradication therapy with multifocal cryoballoon ablation for Barrett esophagus-related neoplasia: a prospective European multicenter study

Authors

  • Charlotte N. Frederiks  ‡

    1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
    2   Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands

  • Anouk Overwater‡

    1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
    2   Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands

  • Torsten Beyna 

    3   Department of Internal Medicine and Gastroenterology, Evangelical Hospital Dusseldorf, Düsseldorf, Germany

  • Horst Neuhaus

    3   Department of Internal Medicine and Gastroenterology, Evangelical Hospital Dusseldorf, Düsseldorf, Germany

  • Raf Bisschops 

    4   Department of Gastroenterology and Hepatology, University Hospital Gasthuisberg Leuven, KU Leuven, Leuven, Belgium
    5   Translational Research Center for Gastrointestinal Disorders, KU Leuven, Leuven, Belgium

  • Roos E. Pouw

    1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
    6   Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
    7   Amsterdam Gastroenterology Endocrinology Metabolism, Cancer Center Amsterdam, Amsterdam, The Netherlands

  • Jacques J. G. H. M. Bergman

    6   Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
    7   Amsterdam Gastroenterology Endocrinology Metabolism, Cancer Center Amsterdam, Amsterdam, The Netherlands

  • Maximilien Barret

    8   Department of Gastroenterology and Digestive Oncology, Cochin Hospital, Paris, France

  • Roberta Maselli

    9   Endoscopy Unit, Humanitas Research Hospital, Milan, Italy

  • Vinay Sehgal

    10   Department of Gastroenterology and Hepatology, University College London Hospitals, London, United Kingdom of Great Britain and Northern Ireland

  • Rehan J. Haidry

    11   Department of Gastroenterology and Hepatology, Cleveland Clinic London, London, United Kingdom of Great Britain and Northern Ireland

  • Bas L.A.M. Weusten 

    2   Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands
    1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands

This study was financially supported by PENTAX Medical GmbH. Each participating site received the required endoscopy material free of charge during the course of the study as well as a fixed fee to cover the costs associated with study participation. In addition, the study coordinators were compensated for any study related travel costs.

Clinical Trial:

Registration number (trial ID): NL-OMON50590, Trial registry: Netherlands National Trial Register (http://www.trialregister.nl), Type of Study: Prospective, multicenter, single-arm, intervention study


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Graphical Abstract

Abstract

Background

Focal cryoballoon ablation (FCBA) is a relatively new modality for treatment of Barrett esophagus (BE)-related neoplasia. This study evaluated the efficacy and safety of FCBA for BE.

Methods

Patients with BE segments (Prague classification C≤2M≤5) with dysplasia or early cancer were eligible for inclusion. Following endoscopic resection of visible lesions, FCBA was performed at 3-month intervals until complete eradication of BE (maximum five sessions). After ≥2 FCBA sessions, add-on treatment was allowed. Follow-up endoscopy was scheduled at 6 months and annually thereafter. Outcomes were complete eradication of endoscopically visible BE (CE-BE), intestinal metaplasia (CE-IM), and dysplasia (CE-D), durability of treatment response, and adverse events.

Results

107 patients (mean age 65 years, 91 males, median BE C0M2) were included. Endoscopic resection was performed at entry in 65% (69/107). Patients received a median of 2 FCBA treatments. Add-on treatment was performed in 40% (43/107), mainly APC for small remaining islands (38%; 41/107). CE-BE and CE-D were achieved in 94% (101/107; 95%CI 90%–98%) and CE-IM in 91% (97/107; 95%CI 85%–95%), per intention-to-treat analysis. In per-protocol analysis, CE-BE and CE-D was achieved in 100% (101/101; 95%CI 100%–100%), and CE-IM in 96% (97/101; 95%CI 92%–99%). After a median follow-up of 18 months, 96% (97/101; 95%CI 92%–99%) remained free of endoscopically visible BE. Esophageal stricture was the most common adverse event, in 13% (13/101; 95%CI 6%–20%).

Conclusion

FCBA was highly effective in selected patients with BE of limited length, although the potential risk for stricture formation warrants further research.

Supplementary Material



Publication History

Received: 30 January 2025

Accepted after revision: 25 September 2025

Accepted Manuscript online:
26 September 2025

Article published online:
19 November 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).

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