TY - JOUR
T1 - Multifocal Cryoballoon Ablation for Eradication of Barrett's Esophagus-Related Neoplasia
T2 - A Prospective Multicenter Clinical Trial
AU - Canto, Marcia Irene
AU - Trindade, Arvind J.
AU - Abrams, Julian
AU - Rosenblum, Michael
AU - Dumot, John
AU - Chak, Amitabh
AU - Iyer, Prasad
AU - Diehl, David
AU - Khara, Harshit S.
AU - Corbett, F. Scott
AU - McKinley, Matthew
AU - Shin, Eun Ji
AU - Waxman, Irving
AU - Infantolino, Anthony
AU - Tofani, Christina
AU - Samarasena, Jason
AU - Chang, Kenneth
AU - Wang, Bingkai
AU - Goldblum, John
AU - Voltaggio, Lysandra
AU - Montgomery, Elizabeth
AU - Lightdale, Charles J.
AU - Shaheen, Nicholas J.
N1 - Funding Information:
Financial support: Research grant from C2 Cryoballoon/Pentax Medical Corporation; statistical analysis supported by Johns Hopkins Institute for Clinical and Translational Research (ICTR). The sponsor maintained the study database but played no role in the study design, analysis, or interpretation of the data.
Funding Information:
Potential competing interests: M.I.C.: royalty from UpToDate, research grant recipient from Endogastric Solutions and C2 Therapeutics/Pentax Medical Corporation; consultant for Exigo Management Consultants and Exact Sciences. A.J.T.: consultant for Pentax Medical and Olympus America; research grant from Nine Point Medical. J.A.: consultant for C2 Therapeutics. M.R.: President of Evolution Trial Design, Inc. J.D.S: research grant CSA Medical. A.C.: equity holder for Lucid Diagnostics; consultant for Interspace Diagnostics; research grant C2 Therapeutics/Pentax Medical Corporation. P.I.: research funding from Exact Sciences, C2 Therapeutics, Medtronic, Nine Point Medical; consultant C2 Therapeutics, Medtronic, CSA Medical. E.J.S.: consultant Boston Scientific and Medtronic. K.C.: consultant for Apollo Endosurgery, C2 Therapeutics/Pentax Medical Corporation, Cook Medical, Endogastric Solutions, Medtronic, Olympus, Ovesco. L.V.: CT Therapeutics/Pentax Medical Corporation salary support for research. E.M.: CT therapeutics/Pentax Medical Corporation salary support for research. CJ Lightdale: consultant for C2 Therapeutics, Boston Scientific, and CDX Diagnostics. N.J.S. consultant for Boston Scientific, Cook Medical, Cernostics, and Shire; research grant recipient from CDx Medical, C2 Therapeutics/Pentax Medical Corporation, Medtronic, Interpace Diagnostics, Lucid Diagnostics, and CSA Medical. All remaining co-authors have no disclosures. Study Highlights WHAT IS KNOWN
Publisher Copyright:
© 2020 Wolters Kluwer Health. All rights reserved.
PY - 2020/11/1
Y1 - 2020/11/1
N2 - INTRODUCTION:Ablation of Barrett's esophagus (BE) is the preferred approach for the treatment of neoplasia without visible lesions. Limited data on cryoballoon ablation (CBA) suggest its potential clinical utility. We evaluated the safety and efficacy of CBA in a multicenter study of patients with neoplastic BE.METHODS:In a prospective clinical trial, 11 academic and community centers recruited consecutive patients with BE of 1-6 cm length and low-grade dysplasia, high-grade dysplasia (HGD), or intramucosal adenocarcinoma (ImCA) confirmed by central pathology. Patients with symptomatic pre-existing strictures or visible BE lesions had dilation or endoscopic mucosal resection (EMR), respectively, before enrollment. A nitrous oxide cryoballoon focal ablation system was used to treat all visible columnar mucosa in up to 5 sessions. Study end points included complete eradication of all dysplasia (CE-D) and intestinal metaplasia (CE-IM) at 1 year.RESULTS:One hundred twenty patients with BE with ImCA (20%), HGD (56%), or low-grade dysplasia (23%) were enrolled. In the intention-to-treat analysis, the CE-D and CE-IM rates were 76% and 72%, respectively. In the per-protocol analysis (94 patients), the CE-D and CE-IM rates were 97% and 91%, respectively. Postablation pain was mild and short lived. Fifteen subjects (12.5%) developed strictures requiring dilation. One patient (0.8%) with HGD progressed to ImCA, which was successfully treated with EMR. Another patient (0.8%) developed gastrointestinal bleeding associated with clopidogrel use. One patient (0.8%) had buried BE with HGD in 1 biopsy, not confirmed by subsequent EMR.DISCUSSION:In patients with neoplastic BE, CBA was safe and effective. Head-to-head comparisons between CBA and other ablation modalities are warranted (clinicaltrials.gov registration NCT02514525).
AB - INTRODUCTION:Ablation of Barrett's esophagus (BE) is the preferred approach for the treatment of neoplasia without visible lesions. Limited data on cryoballoon ablation (CBA) suggest its potential clinical utility. We evaluated the safety and efficacy of CBA in a multicenter study of patients with neoplastic BE.METHODS:In a prospective clinical trial, 11 academic and community centers recruited consecutive patients with BE of 1-6 cm length and low-grade dysplasia, high-grade dysplasia (HGD), or intramucosal adenocarcinoma (ImCA) confirmed by central pathology. Patients with symptomatic pre-existing strictures or visible BE lesions had dilation or endoscopic mucosal resection (EMR), respectively, before enrollment. A nitrous oxide cryoballoon focal ablation system was used to treat all visible columnar mucosa in up to 5 sessions. Study end points included complete eradication of all dysplasia (CE-D) and intestinal metaplasia (CE-IM) at 1 year.RESULTS:One hundred twenty patients with BE with ImCA (20%), HGD (56%), or low-grade dysplasia (23%) were enrolled. In the intention-to-treat analysis, the CE-D and CE-IM rates were 76% and 72%, respectively. In the per-protocol analysis (94 patients), the CE-D and CE-IM rates were 97% and 91%, respectively. Postablation pain was mild and short lived. Fifteen subjects (12.5%) developed strictures requiring dilation. One patient (0.8%) with HGD progressed to ImCA, which was successfully treated with EMR. Another patient (0.8%) developed gastrointestinal bleeding associated with clopidogrel use. One patient (0.8%) had buried BE with HGD in 1 biopsy, not confirmed by subsequent EMR.DISCUSSION:In patients with neoplastic BE, CBA was safe and effective. Head-to-head comparisons between CBA and other ablation modalities are warranted (clinicaltrials.gov registration NCT02514525).
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U2 - 10.14309/ajg.0000000000000822
DO - 10.14309/ajg.0000000000000822
M3 - Article
C2 - 33156107
AN - SCOPUS:85095862264
SN - 0002-9270
VL - 115
SP - 1879
EP - 1890
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
IS - 11
ER -