TY - JOUR
T1 - Comparison of focal cryoballoon ablation with 10- and 8-second doses for treatment of Barrett's esophagus–related neoplasia
T2 - results from a prospective European multicenter study (with video)
AU - Frederiks, Charlotte N.
AU - Overwater, Anouk
AU - Alvarez Herrero, Lorenza
AU - Alkhalaf, Alaa
AU - Schenk, Ed
AU - Repici, Alessandro
AU - Bergman, Jacques J. G. H. M.
AU - Pouw, Roos E.
AU - Bisschops, Raf
AU - Haidry, Rehan J.
AU - Beyna, Torsten
AU - Neuhaus, Horst
AU - Weusten, Bas L. A. M.
N1 - 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
PY - 2022/11
Y1 - 2022/11
N2 - 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 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.)
AB - 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 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.)
UR - http://www.scopus.com/inward/record.url?scp=85139076555&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.gie.2022.06.017
DO - https://doi.org/10.1016/j.gie.2022.06.017
M3 - Article
C2 - 35724692
SN - 0016-5107
VL - 96
SP - 743-751.e4
JO - Gastrointestinal Endoscopy
JF - Gastrointestinal Endoscopy
IS - 5
ER -