Marcia Irene Canto1, Arvind J Trindade2, Julian Abrams3, Michael Rosenblum4, John Dumot5, Amitabh Chak5, Prasad Iyer6, David Diehl7, Harshit S Khara7, F Scott Corbett8, Matthew McKinley2, Eun Ji Shin1, Irving Waxman9, Anthony Infantolino10, Christina Tofani9, Jason Samarasena11, Kenneth Chang11, Bingkai Wang4, John Goldblum12, Lysandra Voltaggio13, Elizabeth Montgomery13, Charles J Lightdale2, Nicholas J Shaheen14. 1. Department of Medicine (Gastroenterology), Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. 2. 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. 3. Department of Medicine, Columbia University Medical Center, New York, New York, USA. 4. Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, USA. 5. Division of Gastroenterology at University Hospitals of Cleveland Medical Center, Cleveland, Ohio, USA. 6. Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota, USA. 7. Division of Gastroenterology, Geisinger Medical Center, Danby Pennsylvania, USA. 8. Florida Digestive Health Specialists, Sarasota, Florida, USA. 9. Division of Gastroenterology, University of Chicago Medical Center, Chicago, Illinois, USA. 10. Division of Gastroenterology, Jefferson Medical Center, Philadelphia, Pennsylvania, USA. 11. Division of Gastroenterology, University of California Irvine Medical Center, Irvine, California, USA. 12. Department of Pathology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA. 13. Department ofPathology, Johns Hopkins Medical Institutions Baltimore Maryland, USA. 14. Division of Gastroenterology, University of North Carolina, Chapel Hill, North Carolina, USA.
Abstract
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).
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).
Authors: Mate Knabe; Torsten Beyna; Thomas Rösch; Jacques Bergman; Hendrik Manner; Andrea May; Guido Schachschal; Horst Neuhaus; Jennis Kandler; Bas Weusten; Oliver Pech; Siegbert Faiss; Mario Anders; Michael Vieth; Susanne Sehner; Raf Bisschops; Pradeep Bhandari; Christian Ell; Hanno Ehlken Journal: Am J Gastroenterol Date: 2022-01-01 Impact factor: 12.045
Authors: Amaninder Dhaliwal; Syed M Saghir; Harmeet S Mashiana; Annie Braseth; Banreet S Dhindsa; Daryl Ramai; Pushpak Taunk; Rene Gomez-Esquivel; Aamir Dam; Jason Klapman; Douglas G Adler Journal: World J Gastrointest Endosc Date: 2022-01-16