Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett's esophagus (with video)

Marcia Canto, Nicholas J. Shaheen, Jose Alejandro Almario, Lysandra Voltaggio, Elizabeth Montgomery, Charles J. Lightdale

Research output: Contribution to journalArticle

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.)

Original languageEnglish (US)
JournalGastrointestinal Endoscopy
DOIs
StateAccepted/In press - Jan 1 2018

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Barrett Esophagus
Nitrous Oxide
Metaplasia
Cryotherapy
Adenocarcinoma
Therapeutics
Clinical Trials
Intention to Treat Analysis
Focal Adhesions
Deglutition Disorders
Aspirin
Dilatation
Neoplasms
Pathologic Constriction
Hemorrhage
Safety
Pain

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett's esophagus (with video). / Canto, Marcia; Shaheen, Nicholas J.; Almario, Jose Alejandro; Voltaggio, Lysandra; Montgomery, Elizabeth; Lightdale, Charles J.

In: Gastrointestinal Endoscopy, 01.01.2018.

Research output: Contribution to journalArticle

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AU - Almario, Jose Alejandro

AU - Voltaggio, Lysandra

AU - Montgomery, Elizabeth

AU - Lightdale, Charles J.

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