| Durability of radiofrequency ablation in Barrett's esophagus with dysplasia. | |
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MedLine Citation:
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PMID: 21679712 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND & AIMS: Radiofrequency ablation (RFA) can eradicate dysplasia and intestinal metaplasia in patients with dysplastic Barrett's esophagus (BE), and reduce rates of esophageal adenocarcinoma. We assessed long-term rates of eradication, durability of neosquamous epithelium, disease progression, and safety of RFA in patients with dysplastic BE. METHODS: We performed a randomized trial of 127 subjects with dysplastic BE; after cross-over subjects were included, 119 received RFA. Subjects were followed for a mean time of 3.05 years; the study was extended to 5 years for patients with eradication of intestinal metaplasia at 2 years. Outcomes included eradication of dysplasia or intestinal metaplasia after 2 and 3 years, durability of response, disease progression, and adverse events. RESULTS: After 2 years, 101 of 106 patients had complete eradication of all dysplasia (95%) and 99 of 106 had eradication of intestinal metaplasia (93%). After 2 years, among subjects with initial low-grade dysplasia, all dysplasia was eradicated in 51 of 52 (98%) and intestinal metaplasia was eradicated in 51 of 52 (98%); among subjects with initial high-grade dysplasia, all dysplasia was eradicated in 50 of 54 (93%) and intestinal metaplasia was eradicated in 48 of 54 (89%). After 3 years, dysplasia was eradicated in 55 of 56 of subjects (98%) and intestinal metaplasia was eradicated in 51 of 56 (91%). Kaplan-Meier analysis showed that dysplasia remained eradicated in >85% of patients and intestinal metaplasia in >75%, without maintenance RFA. Serious adverse events occurred in 4 of 119 subjects (3.4%); the rate of stricture was 7.6%. The rate of esophageal adenocarcinoma was 1 per 181 patient-years (0.55%/patient-years); there was no cancer-related morbidity or mortality. The annual rate of any neoplastic progression was 1 per 73 patient-years (1.37%/patient-years). CONCLUSIONS: In subjects with dysplastic BE, RFA therapy has an acceptable safety profile, is durable, and is associated with a low rate of disease progression, for up to 3 years. |
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Authors:
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Nicholas J Shaheen; Bergein F Overholt; Richard E Sampliner; Herbert C Wolfsen; Kenneth K Wang; David E Fleischer; Virender K Sharma; Glenn M Eisen; M Brian Fennerty; John G Hunter; Mary P Bronner; John R Goldblum; Ana E Bennett; Hiroshi Mashimo; Richard I Rothstein; Stuart R Gordon; Steven A Edmundowicz; Ryan D Madanick; Anne F Peery; V Raman Muthusamy; Kenneth J Chang; Michael B Kimmey; Stuart J Spechler; Ali A Siddiqui; Rhonda F Souza; Anthony Infantolino; John A Dumot; Gary W Falk; Joseph A Galanko; Blair A Jobe; Robert H Hawes; Brenda J Hoffman; Prateek Sharma; Amitabh Chak; Charles J Lightdale |
Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't Date: 2011-05-06 |
Journal Detail:
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Title: Gastroenterology Volume: 141 ISSN: 1528-0012 ISO Abbreviation: Gastroenterology Publication Date: 2011 Aug |
Date Detail:
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Created Date: 2011-08-08 Completed Date: 2011-10-13 Revised Date: 2012-09-25 |
Medline Journal Info:
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Nlm Unique ID: 0374630 Medline TA: Gastroenterology Country: United States |
Other Details:
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Languages: eng Pagination: 460-8 Citation Subset: AIM; IM |
Copyright Information:
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Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved. |
Affiliation:
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Center for Esophageal Diseases and Swallowing, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7080, USA. nshaheen@med.unc.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00282672 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adenocarcinoma
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pathology* Aged Barrett Esophagus / pathology*, surgery* Catheter Ablation / adverse effects, methods* Disease Progression Epithelium / pathology Esophageal Neoplasms / pathology* Esophagoscopy Esophagus / pathology* Female Humans Kaplan-Meier Estimate Longitudinal Studies Male Metaplasia Middle Aged Precancerous Conditions / pathology*, surgery* Treatment Outcome Watchful Waiting* |
| Grant Support | |
ID/Acronym/Agency:
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P30 DK034987/DK/NIDDK NIH HHS; P30 DK034987-27/DK/NIDDK NIH HHS |
| Comments/Corrections | |
Comment In:
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Gastroenterology. 2011 Aug;141(2):417-9
[PMID:
21708153
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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