Comparison of focal cryoballoon ablation with 10- and 8-second doses for treatment of Barrett's esophagus–related neoplasia: results from a prospective European multicenter study (with video)
Frederiks, Charlotte N; Overwater, Anouk; Herrero, Lorenza Alvarez; Alkhalaf, Alaa; Schenk, Boudewijn E; Repici, Alessandro; Bergman, Jacques J G H M; Pouw, Roos E; Bisschops, Raf; Haidry, Rehan J; Beyna, Torsten; Neuhaus, Horst; Weusten, Bas L A M
(2022) Gastrointestinal Endoscopy, volume 96, issue 5, pp. 743 - 751.e4
(Article)
Abstract
BACKGROUND AND AIMS: Focal cryoballoon ablation (FCBA) is currently being investigated for the treatment of Barrett's esophagus (BE)-related neoplasia in a European multicenter study (Euro-Coldplay study). After inclusion of 28 of 107 patients, the initial dose of 10 seconds was lowered to 8 seconds. The current study aimed to compare
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the efficacy and safety of a single FCBA treatment session with 10 seconds versus 8 seconds. METHODS: Treatments were performed at 7 European BE referral centers. All 28 patients treated with 10 seconds were compared with 28 consecutive patients treated with 8 seconds. The gastroesophageal junction was ablated circumferentially followed by all visible BE. To assess efficacy and safety, 3 expert adjudicators, blinded to physician and dose, compared pre- and post-treatment images. Primary outcomes were median BE surface regression and stricture rate after single-session FCBA. RESULTS: We included 56 patients (10-second cohort, n = 28; 8-second cohort, n = 28) with a median BE length of C0M2 (Prague classification). Baseline characteristics did not significantly differ between the cohorts. The median BE surface regression after a single FCBA session was comparable for 10 seconds and 8 seconds (80% [95% confidence interval {CI}, 75-90] and 80% [95% CI, 66-90], respectively; P = .65). Strictures requiring dilation were seen in 19% (95% CI, 4-33) and 15% (95% CI, 4-30) of the 10-second and 8-second groups, respectively (P = 1.00). Two patients in the 10-second group developed a severe stricture requiring >3 dilations. CONCLUSIONS: In patients with limited BE, single-session FCBA with 8 seconds showed similar BE surface regression as compared with 10 seconds and may theoretically result in fewer and less severe strictures. Therefore, we suggest using 8 seconds as the standard dose for FCBA. (Clinical trial registration number: NL7253.).
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Keywords: Gastroenterology, Radiology Nuclear Medicine and imaging, Journal Article
ISSN: 0016-5107
Publisher: Mosby Inc.
Note: Funding Information: DISCLOSURE: The following authors disclosed financial relationships: C. N. Frederiks, A. Overwater: Reimbursement for travel costs from Pentax Medical. J. J. G. H. M. Bergman: Consultant for Medtronic , Cook Medical , and Boston Scientific; research support from Pentax Medical, C2 Therapeutics, Medtronic , Aqua Medical, Olympus Endoscopy, and Fujifilm . R. E. Pouw: Consultant for MicroTech and Medtronic; speaker for Pentax Medical. R. Bisschops: Consultant for Pentax Medical, Medtronic , and Erbe Medical; research support from and speaker for Pentax Medical, Medtronic , and Erbe Medical. T. Beyna: Consultant for Medtronic, Erbe Medical, Microtech Endoscopy, Olympus Endoscopy, and Boston Scientific. B. L. A. M. Weusten: Research support from Pentax Medical, C2 Therapeutics, and Aqua Medical. All other authors disclosed no financial relationships. This study was financially supported by Pentax Medical of America, Inc. Funding Information: DISCLOSURE: The following authors disclosed financial relationships: C. N. Frederiks, A. Overwater: Reimbursement for travel costs from Pentax Medical. J. J. G. H. M. Bergman: Consultant for Medtronic, Cook Medical, and Boston Scientific; research support from Pentax Medical, C2 Therapeutics, Medtronic, Aqua Medical, Olympus Endoscopy, and Fujifilm. R. E. Pouw: Consultant for MicroTech and Medtronic; speaker for Pentax Medical. R. Bisschops: Consultant for Pentax Medical, Medtronic, and Erbe Medical; research support from and speaker for Pentax Medical, Medtronic, and Erbe Medical. R. Haidry: Research funding from Medtronic, Cook Medical, Fractyl, Pentax Medical, and C2 Therapeutics. T. Beyna: Consultant for Medtronic, Erbe Medical, Microtech Endoscopy, Olympus Endoscopy, and Boston Scientific. B. L. A. M. Weusten: Research support from Pentax Medical, C2 Therapeutics, and Aqua Medical. All other authors disclosed no financial relationships. This study was financially supported by Pentax Medical of America, Inc. Publisher Copyright: © 2022 American Society for Gastrointestinal Endoscopy
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