TY - JOUR
T1 - Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett's esophagus (with video)
AU - Canto, Marcia Irene
AU - Shaheen, Nicholas J.
AU - Almario, Jose Alejandro
AU - Voltaggio, Lysandra
AU - Montgomery, Elizabeth
AU - Lightdale, Charles J.
N1 - Funding Information:
DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: M. I. Canto: Consultant for Pentax Medical Corp; 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. 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.
Publisher Copyright:
© 2018 American Society for Gastrointestinal Endoscopy
PY - 2018/9
Y1 - 2018/9
N2 - 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.)
AB - 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.)
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U2 - 10.1016/j.gie.2018.03.024
DO - 10.1016/j.gie.2018.03.024
M3 - Article
C2 - 29626424
AN - SCOPUS:85047217907
SN - 0016-5107
VL - 88
SP - 438-446.e2
JO - Gastrointestinal endoscopy
JF - Gastrointestinal endoscopy
IS - 3
ER -