title: A simplified regimen for focal radiofrequency ablation of Barrett's mucosa: a randomized multicenter trial comparing two ablation regimens.
abstract: BACKGROUND
  The currently recommended regimen for focal radiofrequency ablation (RFA) of Barrett's esophagus (BE) comprises 2 applications of energy, cleaning of the device and ablation zone, and 2 additional applications of energy. A simplified regimen may be of clinical utility if it is faster, easier, and equally safe and effective.
  
  
  OBJECTIVE
  To compare the efficacy of 2 focal RFA regimens.
  
  
  METHODS
  Three tertiary referral centers.
  
  
  METHODS
  Consecutive patients scheduled for focal RFA of BE with flat type BE with at least 2 BE islands or mosaic groups of islands were enrolled.
  
  
  METHODS
  BE areas were paired: 1 area was randomized to the "standard" regimen (2 × 15 J/cm(2)-clean-2 × 15 J/cm(2)) or to the "simplified" regimen (3 × 15 J/cm(2)-no clean), allocating the second area automatically to the other regimen. The percentage of surface area regression of each area was scored at 2 months by the endoscopist (blinded).
  
  
  METHODS
  Proportion of completely removed BE areas at 2 months. Calculated sample size was 46 pairs of BE areas using a noninferiority design. Noninferiority was defined as <20% difference in the paired proportions.
  
  
  RESULTS
  Forty-five equivalent pairs of BE areas were included in 41 patients. The proportion of completely removed BE areas at 2 months after focal RFA was 30 (67%) for standard and 33 (73%) for simplified. Noninferiority was demonstrated by a 7% difference (95% CI, -10.6 to +20.9).
  
  
  CONCLUSIONS
  Tertiary referral centers.
  
  
  CONCLUSIONS
  The results of this multicenter randomized trial suggest that a simplified 3 × 15 J/cm(2) focal ablation regimen is not inferior to the standard regimen, regarding the endoscopic removal of residual Barrett islands.
authors.affiliation: Department of Gastroenterology, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Frederike G I
authors.initials: FG
authors.lastname: van Vilsteren
authors.forename: K Nadine
authors.initials: KN
authors.lastname: Phoa
authors.forename: Lorenza
authors.initials: L
authors.lastname: Alvarez Herrero
authors.forename: Roos E
authors.initials: RE
authors.lastname: Pouw
authors.forename: Carine M T
authors.initials: CM
authors.lastname: Sondermeijer
authors.forename: Mike
authors.initials: M
authors.lastname: Visser
authors.forename: Fiebo J W
authors.initials: FJ
authors.lastname: Ten Kate
authors.forename: Mark I
authors.initials: MI
authors.lastname: van Berge Henegouwen
authors.forename: Bas L A M
authors.initials: BL
authors.lastname: Weusten
authors.forename: Erik J
authors.initials: EJ
authors.lastname: Schoon
authors.forename: Jacques J G H M
authors.initials: JJ
authors.lastname: Bergman
mesh_terms: D000368:Aged; D001471:Barrett Esophagus / Q000473:pathology / Q000601:surgery*; D017115:Catheter Ablation / Q000295:instrumentation / Q000379:methods*; D057785:Catheters; D004502:Education, Medical, Continuing; D004938:Esophageal Neoplasms / Q000517:prevention & control; D004945:Esophagoscopy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D009092:Mucous Membrane / Q000473:pathology / Q000601:surgery; D009426:Netherlands; D061646:Operative Time; D018579:Patient Selection; D011230:Precancerous Conditions / Q000473:pathology / Q000601:surgery*; D018570:Risk Assessment; D062606:Tertiary Care Centers; D013997:Time Factors; D016896:Treatment Outcome