Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett’s esophagus (with video) - 15/08/18
Abstract |
Background and Aims |
Endoscopic cryotherapy can eradicate neoplastic Barrett’s esophagus (BE). A new contact cryoballoon focal ablation system (CbFAS)) freezes esophageal mucosa with nitrous oxide. We studied the safety and efficacy of CbFAS for complete eradication of neoplastic Barrett's esophagus.
Methods |
In a prospective clinical trial, consecutive BE patients with confirmed neoplasia (low-grade dysplasia [LGD], high-grade dysplasia [HGD], and/or intramucosal adenocarcinoma [ImCA]), at least 1 cm of BE, with or without prior ablation, were treated with a dose 10 seconds of spray per site. EMR was performed for nodular lesions. Treatments were repeated every 10 to 12 weeks until complete eradication, with a maximum of 5 treatments. Primary outcomes were complete eradication of all dysplasia (CE-D) and complete eradication of intestinal metaplasia (CE-IM) at 1 year (intention-to-treat analysis).
Results |
Forty-one assessable patients (22 treatment naive, 19 previously ablated) with LGD (n = 13), HGD (n = 23), or ImCA (n = 5) were treated. The median procedure time was 30 minutes. The median number of ablation procedures for CE-IM was 3 (interquartile range, 2-4). Overall 1-year CE-D and CE-IM rates were 95% and 88%, respectively. CE-D rate was significantly lower (67%) in those with ultra-long BE compared with those with <8 cm (100%, P = .02). Median pain scores were zero at day 1. Four patients (9.7%) developed mild dysphagia from stenoses requiring dilation. One patient on aspirin developed upper GI bleeding that did not require therapy.
Conclusions |
Multifocal nitrous oxide cryotherapy using CbFAS is a promising, highly effective, and safe endoscopic treatment for primary or rescue therapy of BE-associated neoplasia and IM. (Clinical trial registration number: NCT02534233.)
Le texte complet de cet article est disponible en PDF.Abbreviations : APC, BE, CbFAS, CE-D, CE-IM, HGD, IM, ImCA, LGD, RFA
Plan
| DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: M. I. Canto: Royalty from UpToDate; research grant recipient from C2 Therapeutics and Cosmo Pharmaceuticals; speaker for Cook Medical. N. J. Shaheen: Consultant for Boston Scientific, Cook Medical, and Shire; research grant recipient from CDX Medical, C2 Therapeutics, and CSA Medical. C. J. Lightdale: Consultant for C2 Therapeutics, Boston Scientific, and CDx Diagnostics; L. Voltaggio: Research Grant Salary Support from C2 Therapeutics. All other authors disclosed no financial relationships relevant to this publication. Research support for this study was provided by an unrestricted research grant from C2 Therapeutics, Inc. |
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| See CME section; p. 542. |
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| If you would like to chat with an author of this article, you may contact Dr Canto at mcanto@jhmi.edu. |
Vol 88 - N° 3
P. 438 - septembre 2018 Retour au numéro
Article précédent
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