title: Radiofrequency ablation in Barrett's esophagus with dysplasia.
abstract: BACKGROUND
  Barrett's esophagus, a condition of intestinal metaplasia of the esophagus, is associated with an increased risk of esophageal adenocarcinoma. We assessed whether endoscopic radiofrequency ablation could eradicate dysplastic Barrett's esophagus and decrease the rate of neoplastic progression.
  
  
  METHODS
  In a multicenter, sham-controlled trial, we randomly assigned 127 patients with dysplastic Barrett's esophagus in a 2:1 ratio to receive either radiofrequency ablation (ablation group) or a sham procedure (control group). Randomization was stratified according to the grade of dysplasia and the length of Barrett's esophagus. Primary outcomes at 12 months included the complete eradication of dysplasia and intestinal metaplasia.
  
  
  RESULTS
  In the intention-to-treat analyses, among patients with low-grade dysplasia, complete eradication of dysplasia occurred in 90.5% of those in the ablation group, as compared with 22.7% of those in the control group (P<0.001). Among patients with high-grade dysplasia, complete eradication occurred in 81.0% of those in the ablation group, as compared with 19.0% of those in the control group (P<0.001). Overall, 77.4% of patients in the ablation group had complete eradication of intestinal metaplasia, as compared with 2.3% of those in the control group (P<0.001). Patients in the ablation group had less disease progression (3.6% vs. 16.3%, P=0.03) and fewer cancers (1.2% vs. 9.3%, P=0.045). Patients reported having more chest pain after the ablation procedure than after the sham procedure. In the ablation group, one patient had upper gastrointestinal hemorrhage, and five patients (6.0%) had esophageal stricture.
  
  
  CONCLUSIONS
  In patients with dysplastic Barrett's esophagus, radiofrequency ablation was associated with a high rate of complete eradication of both dysplasia and intestinal metaplasia and a reduced risk of disease progression. (ClinicalTrials.gov number, NCT00282672.)
authors.affiliation: Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, CB 7080, Chapel Hill, NC 27599-7080, USA. nshaheen@med.unc.edu
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Shaheen
authors.forename: Prateek
authors.initials: P
authors.lastname: Sharma
authors.forename: Bergein F
authors.initials: BF
authors.lastname: Overholt
authors.forename: Herbert C
authors.initials: HC
authors.lastname: Wolfsen
authors.forename: Richard E
authors.initials: RE
authors.lastname: Sampliner
authors.forename: Kenneth K
authors.initials: KK
authors.lastname: Wang
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Galanko
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: Blair A
authors.initials: BA
authors.lastname: Jobe
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: David E
authors.initials: DE
authors.lastname: Fleischer
authors.forename: Virender K
authors.initials: VK
authors.lastname: Sharma
authors.forename: Robert H
authors.initials: RH
authors.lastname: Hawes
authors.forename: Brenda J
authors.initials: BJ
authors.lastname: Hoffman
authors.forename: Richard I
authors.initials: RI
authors.lastname: Rothstein
authors.forename: Stuart R
authors.initials: SR
authors.lastname: Gordon
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Mashimo
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Chang
authors.forename: V Raman
authors.initials: VR
authors.lastname: Muthusamy
authors.forename: Steven A
authors.initials: SA
authors.lastname: Edmundowicz
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: Gary W
authors.initials: GW
authors.lastname: Falk
authors.forename: Michael B
authors.initials: MB
authors.lastname: Kimmey
authors.forename: Ryan D
authors.initials: RD
authors.lastname: Madanick
authors.forename: Amitabh
authors.initials: A
authors.lastname: Chak
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Lightdale
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001471:Barrett Esophagus / Q000473:pathology / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects; D018450:Disease Progression; D004947:Esophagus / Q000473:pathology* / Q000601:surgery; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008679:Metaplasia / Q000601:surgery; D008875:Middle Aged; D016896:Treatment Outcome