title: Durability of radiofrequency ablation in Barrett's esophagus with dysplasia.
abstract: OBJECTIVE
  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.
authors.affiliation: Center for Esophageal Diseases and Swallowing, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7080, USA. nshaheen@med.unc.edu
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Shaheen
authors.forename: Bergein F
authors.initials: BF
authors.lastname: Overholt
authors.forename: Richard E
authors.initials: RE
authors.lastname: Sampliner
authors.forename: Herbert C
authors.initials: HC
authors.lastname: Wolfsen
authors.forename: Kenneth K
authors.initials: KK
authors.lastname: Wang
authors.forename: David E
authors.initials: DE
authors.lastname: Fleischer
authors.forename: Virender K
authors.initials: VK
authors.lastname: Sharma
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Eisen
authors.forename: M Brian
authors.initials: MB
authors.lastname: Fennerty
authors.forename: John G
authors.initials: JG
authors.lastname: Hunter
authors.forename: Mary P
authors.initials: MP
authors.lastname: Bronner
authors.forename: John R
authors.initials: JR
authors.lastname: Goldblum
authors.forename: Ana E
authors.initials: AE
authors.lastname: Bennett
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Mashimo
authors.forename: Richard I
authors.initials: RI
authors.lastname: Rothstein
authors.forename: Stuart R
authors.initials: SR
authors.lastname: Gordon
authors.forename: Steven A
authors.initials: SA
authors.lastname: Edmundowicz
authors.forename: Ryan D
authors.initials: RD
authors.lastname: Madanick
authors.forename: Anne F
authors.initials: AF
authors.lastname: Peery
authors.forename: V Raman
authors.initials: VR
authors.lastname: Muthusamy
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Chang
authors.forename: Michael B
authors.initials: MB
authors.lastname: Kimmey
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Spechler
authors.forename: Ali A
authors.initials: AA
authors.lastname: Siddiqui
authors.forename: Rhonda F
authors.initials: RF
authors.lastname: Souza
authors.forename: Anthony
authors.initials: A
authors.lastname: Infantolino
authors.forename: John A
authors.initials: JA
authors.lastname: Dumot
authors.forename: Gary W
authors.initials: GW
authors.lastname: Falk
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Galanko
authors.forename: Blair A
authors.initials: BA
authors.lastname: Jobe
authors.forename: Robert H
authors.initials: RH
authors.lastname: Hawes
authors.forename: Brenda J
authors.initials: BJ
authors.lastname: Hoffman
authors.forename: Prateek
authors.initials: P
authors.lastname: Sharma
authors.forename: Amitabh
authors.initials: A
authors.lastname: Chak
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Lightdale
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology*; D000368:Aged; D001471:Barrett Esophagus / Q000473:pathology* / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods*; D018450:Disease Progression; D004848:Epithelium / Q000473:pathology; D004938:Esophageal Neoplasms / Q000473:pathology*; D004945:Esophagoscopy; D004947:Esophagus / Q000473:pathology*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008297:Male; D008679:Metaplasia; D008875:Middle Aged; D011230:Precancerous Conditions / Q000473:pathology* / Q000601:surgery*; D016896:Treatment Outcome; D057832:Watchful Waiting