Multifocal Cryoballoon Ablation for Eradication of Barrett's Esophagus-Related Neoplasia: A Prospective Multicenter Clinical Trial
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 neoplasti...
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| Published in | The American journal of gastroenterology Vol. 115; no. 11; pp. 1879 - 1890 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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United States
Wolters Kluwer
01.11.2020
Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins |
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| Abstract | 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.
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.
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.
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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| AbstractList | 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.
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.
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.
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). 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). 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.INTRODUCTIONAblation 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.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.METHODSIn 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.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.RESULTSOne 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.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).DISCUSSIONIn 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). |
| Author | Diehl, David Lightdale, Charles J. Samarasena, Jason Tofani, Christina Goldblum, John Dumot, John Waxman, Irving Chak, Amitabh Khara, Harshit S. Voltaggio, Lysandra Chang, Kenneth Shaheen, Nicholas J. Canto, Marcia Irene Shin, Eun Ji Wang, Bingkai Iyer, Prasad Trindade, Arvind J. Rosenblum, Michael Infantolino, Anthony Abrams, Julian McKinley, Matthew Corbett, F. Scott Montgomery, Elizabeth |
| AuthorAffiliation | Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota, USA Division of Gastroenterology, University of California Irvine Medical Center, Irvine, California, USA Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, USA Division of Gastroenterology, Geisinger Medical Center, Danby Pennsylvania, USA Department of Medicine (Gastroenterology), Johns Hopkins Medical Institutions, Baltimore, Maryland, USA Department of Medicine, Columbia University Medical Center, New York, New York, USA Division of Gastroenterology at University Hospitals of Cleveland Medical Center, Cleveland, Ohio, USA Florida Digestive Health Specialists, Sarasota, Florida, USA Department of Pathology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA Division of Gastroenterology, Jefferson Medical Center, Philadelphia, Pennsylvania, USA Division of Gastroenterology at the Zucker School of Medicine of Hofstra/Northwell, Long Island Jewish Medical Center, Northwell Health System, New Hyde Park, |
| AuthorAffiliation_xml | – name: Division of Gastroenterology, University of California Irvine Medical Center, Irvine, California, USA – name: Department of Medicine (Gastroenterology), Johns Hopkins Medical Institutions, Baltimore, Maryland, USA – name: Florida Digestive Health Specialists, Sarasota, Florida, USA – name: Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, USA – name: Department of Medicine, Columbia University Medical Center, New York, New York, USA – name: Division of Gastroenterology, Geisinger Medical Center, Danby Pennsylvania, USA – name: Department of Pathology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA – name: Division of Gastroenterology, Jefferson Medical Center, Philadelphia, Pennsylvania, USA – name: Division of Gastroenterology at the Zucker School of Medicine of Hofstra/Northwell, Long Island Jewish Medical Center, Northwell Health System, New Hyde Park, New York, USA – name: Division of Gastroenterology, University of Chicago Medical Center, Chicago, Illinois, USA – name: Department ofPathology, Johns Hopkins Medical Institutions Baltimore Maryland, USA – name: Division of Gastroenterology, University of North Carolina, Chapel Hill, North Carolina, USA – name: Division of Gastroenterology at University Hospitals of Cleveland Medical Center, Cleveland, Ohio, USA – name: Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota, USA |
| Author_xml | – sequence: 1 givenname: Marcia Irene surname: Canto fullname: Canto, Marcia Irene organization: Department of Medicine (Gastroenterology), Johns Hopkins Medical Institutions, Baltimore, Maryland, USA – sequence: 2 givenname: Arvind J. surname: Trindade fullname: Trindade, Arvind J. organization: Division of Gastroenterology at the Zucker School of Medicine of Hofstra/Northwell, Long Island Jewish Medical Center, Northwell Health System, New Hyde Park, New York, USA – sequence: 3 givenname: Julian surname: Abrams fullname: Abrams, Julian organization: Department of Medicine, Columbia University Medical Center, New York, New York, USA – sequence: 4 givenname: Michael surname: Rosenblum fullname: Rosenblum, Michael organization: Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, USA – sequence: 5 givenname: John surname: Dumot fullname: Dumot, John organization: Division of Gastroenterology at University Hospitals of Cleveland Medical Center, Cleveland, Ohio, USA – sequence: 6 givenname: Amitabh surname: Chak fullname: Chak, Amitabh organization: Division of Gastroenterology at University Hospitals of Cleveland Medical Center, Cleveland, Ohio, USA – sequence: 7 givenname: Prasad surname: Iyer fullname: Iyer, Prasad organization: Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota, USA – sequence: 8 givenname: David surname: Diehl fullname: Diehl, David organization: Division of Gastroenterology, Geisinger Medical Center, Danby Pennsylvania, USA – sequence: 9 givenname: Harshit S. surname: Khara fullname: Khara, Harshit S. organization: Division of Gastroenterology, Geisinger Medical Center, Danby Pennsylvania, USA – sequence: 10 givenname: F. Scott surname: Corbett fullname: Corbett, F. Scott organization: Florida Digestive Health Specialists, Sarasota, Florida, USA – sequence: 11 givenname: Matthew surname: McKinley fullname: McKinley, Matthew organization: Division of Gastroenterology at the Zucker School of Medicine of Hofstra/Northwell, Long Island Jewish Medical Center, Northwell Health System, New Hyde Park, New York, USA – sequence: 12 givenname: Eun Ji surname: Shin fullname: Shin, Eun Ji organization: Department of Medicine (Gastroenterology), Johns Hopkins Medical Institutions, Baltimore, Maryland, USA – sequence: 13 givenname: Irving surname: Waxman fullname: Waxman, Irving organization: Division of Gastroenterology, University of Chicago Medical Center, Chicago, Illinois, USA – sequence: 14 givenname: Anthony surname: Infantolino fullname: Infantolino, Anthony organization: Division of Gastroenterology, Jefferson Medical Center, Philadelphia, Pennsylvania, USA – sequence: 15 givenname: Christina surname: Tofani fullname: Tofani, Christina organization: Division of Gastroenterology, University of Chicago Medical Center, Chicago, Illinois, USA – sequence: 16 givenname: Jason surname: Samarasena fullname: Samarasena, Jason organization: Division of Gastroenterology, University of California Irvine Medical Center, Irvine, California, USA – sequence: 17 givenname: Kenneth surname: Chang fullname: Chang, Kenneth organization: Division of Gastroenterology, University of California Irvine Medical Center, Irvine, California, USA – sequence: 18 givenname: Bingkai surname: Wang fullname: Wang, Bingkai organization: Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, USA – sequence: 19 givenname: John surname: Goldblum fullname: Goldblum, John organization: Department of Pathology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA – sequence: 20 givenname: Lysandra surname: Voltaggio fullname: Voltaggio, Lysandra organization: Department ofPathology, Johns Hopkins Medical Institutions Baltimore Maryland, USA – sequence: 21 givenname: Elizabeth surname: Montgomery fullname: Montgomery, Elizabeth organization: Department ofPathology, Johns Hopkins Medical Institutions Baltimore Maryland, USA – sequence: 22 givenname: Charles J. surname: Lightdale fullname: Lightdale, Charles J. organization: Division of Gastroenterology at the Zucker School of Medicine of Hofstra/Northwell, Long Island Jewish Medical Center, Northwell Health System, New Hyde Park, New York, USA – sequence: 23 givenname: Nicholas J. surname: Shaheen fullname: Shaheen, Nicholas J. organization: Division of Gastroenterology, University of North Carolina, Chapel Hill, North Carolina, USA |
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| Snippet | Ablation of Barrett's esophagus (BE) is the preferred approach for the treatment of neoplasia without visible lesions. Limited data on cryoballoon ablation... INTRODUCTION:Ablation of Barrett's esophagus (BE) is the preferred approach for the treatment of neoplasia without visible lesions. Limited data on cryoballoon... |
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| SubjectTerms | Ablation Adenocarcinoma - pathology Adenocarcinoma - surgery Adult Aged Aged, 80 and over Barrett Esophagus - pathology Barrett Esophagus - surgery Biopsy Catheters Clinical trials Cryosurgery - instrumentation Cryosurgery - methods Cryotherapy Endoscopic Mucosal Resection Endoscopy Esophageal cancer Esophageal Mucosa - pathology Esophageal Mucosa - surgery Esophageal Neoplasms - pathology Esophageal Neoplasms - surgery Female Gastroenterology Humans Male Middle Aged Nitrous oxide Patients Prospective Studies Treatment Outcome |
| Title | Multifocal Cryoballoon Ablation for Eradication of Barrett's Esophagus-Related Neoplasia: A Prospective Multicenter Clinical Trial |
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