title: Circumferential balloon-based radiofrequency ablation of Barrett's esophagus with dysplasia can be simplified, yet efficacy maintained, by omitting the cleaning phase.
abstract: OBJECTIVE
  The current procedure for circumferential balloon-based radiofrequency ablation (c-RFA) for the removal of dysplastic Barrett's esophagus (BE) is labor intensive, comprising 2 ablation passes with a cleaning step to remove debris from the ablation zone and electrode. We compared the safety and efficacy of 3 different c-RFA ablation regimens.
  
  
  METHODS
  We performed a prospective trial of consecutive patients with flat-type BE with high-grade dysplasia. Fifty-seven patients (45 men; age, 64 ± 15 y; 28 with prior endoscopic resection) were assigned randomly to groups that underwent c-RFA with a double application of RFA (12 J/cm(2)). The standard group received c-RFA, with device removal and cleaning, followed by c-RFA; the simple-with-cleaning group underwent c-RFA, with device cleaning without removal, followed by c-RFA; and the simple-no-cleaning group received 2 applications of c-RFA, and the device was not removed or cleaned. The primary outcome was surface regression of BE 3 months later, graded by 2 blinded expert endoscopists. Calculated sample size was 57 patients, based on a noninferiority design.
  
  
  RESULTS
  Median BE surface regression at 3 months was 83% in the standard group, 78% in the simple-with-cleaning group, and 88% in the simple-no-cleaning group (P = .14). RF ablation time was 20 minutes (interquartile range [IQR], 18-25 min) for the standard group, 13 minutes (IQR, 11-15 min) for the simple-with-cleaning group, and 5 minutes (IQR, 5-9 min) for the simple-no-cleaning group (P < .01). The median number of introductions (RFA devices/endoscope) for the standard group was 7, vs 4 for the simple groups (P < .01).
  
  
  CONCLUSIONS
  This randomized, prospective study suggests that c-RFA is easier and faster, but equally safe and effective, when the cleaning phase between ablations is omitted or simplified. Trialregister.nl, NTR 2495.
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: Ineke
authors.initials: I
authors.lastname: van Lijnschoten
authors.forename: Kees A
authors.initials: KA
authors.lastname: Seldenrijk
authors.forename: Mike
authors.initials: M
authors.lastname: Visser
authors.forename: Sybren L
authors.initials: SL
authors.lastname: Meijer
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: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001471:Barrett Esophagus / Q000473:pathology / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome