title: Radiofrequency ablation vs endoscopic surveillance for patients with Barrett esophagus and low-grade dysplasia: a randomized clinical trial.
abstract: OBJECTIVE
  Barrett esophagus containing low-grade dysplasia is associated with an increased risk of developing esophageal adenocarcinoma, a cancer with a rapidly increasing incidence in the western world.
  
  
  OBJECTIVE
  To investigate whether endoscopic radiofrequency ablation could decrease the rate of neoplastic progression.
  
  
  METHODS
  Multicenter randomized clinical trial that enrolled 136 patients with a confirmed diagnosis of Barrett esophagus containing low-grade dysplasia at 9 European sites between June 2007 and June 2011. Patient follow-up ended May 2013.
  
  
  METHODS
  Eligible patients were randomly assigned in a 1:1 ratio to either endoscopic treatment with radiofrequency ablation (ablation) or endoscopic surveillance (control). Ablation was performed with the balloon device for circumferential ablation of the esophagus or the focal device for targeted ablation, with a maximum of 5 sessions allowed.
  
  
  METHODS
  The primary outcome was neoplastic progression to high-grade dysplasia or adenocarcinoma during a 3-year follow-up since randomization. Secondary outcomes were complete eradication of dysplasia and intestinal metaplasia and adverse events.
  
  
  RESULTS
  Sixty-eight patients were randomized to receive ablation and 68 to receive control. Ablation reduced the risk of progression to high-grade dysplasia or adenocarcinoma by 25.0% (1.5% for ablation vs 26.5% for control; 95% CI, 14.1%-35.9%; P < .001) and the risk of progression to adenocarcinoma by 7.4% (1.5% for ablation vs 8.8% for control; 95% CI, 0%-14.7%; P = .03). Among patients in the ablation group, complete eradication occurred in 92.6% for dysplasia and 88.2% for intestinal metaplasia compared with 27.9% for dysplasia and 0.0% for intestinal metaplasia among patients in the control group (P < .001). Treatment-related adverse events occurred in 19.1% of patients receiving ablation (P < .001). The most common adverse event was stricture, occurring in 8 patients receiving ablation (11.8%), all resolved by endoscopic dilation (median, 1 session). The data and safety monitoring board recommended early termination of the trial due to superiority of ablation for the primary outcome and the potential for patient safety issues if the trial continued.
  
  
  CONCLUSIONS
  In this randomized trial of patients with Barrett esophagus and a confirmed diagnosis of low-grade dysplasia, radiofrequency ablation resulted in a reduced risk of neoplastic progression over 3 years of follow-up.
  
  
  BACKGROUND
  trialregister.nl Identifier: NTR1198.
authors.affiliation: Department of Gastroenterology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: K Nadine
authors.initials: KN
authors.lastname: Phoa
authors.affiliation: Department of Gastroenterology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Frederike G I
authors.initials: FG
authors.lastname: van Vilsteren
authors.affiliation: Department of Gastroenterology, St Antonius Hospital, Nieuwegein, the Netherlands.
authors.forename: Bas L A M
authors.initials: BL
authors.lastname: Weusten
authors.affiliation: Department of Gastroenterology, University Hospital Leuven, Leuven, Belgium.
authors.forename: Raf
authors.initials: R
authors.lastname: Bisschops
authors.affiliation: Department of Gastroenterology, Catharina Hospital, Eindhoven, the Netherlands.
authors.forename: Erik J
authors.initials: EJ
authors.lastname: Schoon
authors.affiliation: Department of Gastroenterology, Queens Medical Center, Nottingham, England.
authors.forename: Krish
authors.initials: K
authors.lastname: Ragunath
authors.affiliation: Department of Surgical Gastroenterology, Glasgow Royal Infirmary, Glasgow, Scotland.
authors.forename: Grant
authors.initials: G
authors.lastname: Fullarton
authors.affiliation: Medical Research Council, Cancer Unit, Addenbrookes Hospital, Cambridge, England.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Di Pietro
authors.affiliation: Department of Clinical Medicine and Gastroenterology, St James's Hospital, Dublin, Ireland.
authors.forename: Narayanasamy
authors.initials: N
authors.lastname: Ravi
authors.affiliation: Department of Pathology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Mike
authors.initials: M
authors.lastname: Visser
authors.affiliation: Department of Pathology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: G Johan
authors.initials: GJ
authors.lastname: Offerhaus
authors.affiliation: Department of Pathology, St Antonius Hospital, Nieuwegein, the Netherlands.
authors.forename: Cees A
authors.initials: CA
authors.lastname: Seldenrijk
authors.affiliation: Department of Pathology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Sybren L
authors.initials: SL
authors.lastname: Meijer
authors.affiliation: Department of Pathology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Fiebo J W
authors.initials: FJ
authors.lastname: ten Kate
authors.affiliation: Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Jan G P
authors.initials: JG
authors.lastname: Tijssen
authors.affiliation: Department of Gastroenterology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Jacques J G H M
authors.initials: JJ
authors.lastname: Bergman
mesh_terms: D000230:Adenocarcinoma / Q000209:etiology / Q000517:prevention & control*; D000368:Aged; D001471:Barrett Esophagus / Q000145:classification / Q000150:complications / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods; D018450:Disease Progression; D004938:Esophageal Neoplasms / Q000209:etiology / Q000517:prevention & control*; D004945:Esophagoscopy; D004947:Esophagus / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D057832:Watchful Waiting