title: Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett's oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial.
abstract: OBJECTIVE
  After focal endoscopic resection (ER) of high-grade dysplasia (HGD) or early cancer (EC) in Barrett's oesophagus (BO), eradication of all remaining BO reduces the recurrence risk. The aim of this study was to compare the safety of stepwise radical ER (SRER) versus focal ER followed by radiofrequency ablation (RFA) for complete eradication of BO containing HGD/EC.
  
  
  METHODS
  A multicentre randomised clinical trial was carried out in three tertiary centres. Patients with BO ≤ 5 cm containing HGD/EC were randomised to SRER or ER/RFA. Patients in the SRER group underwent piecemeal ER of 50% of BO followed by serial ER. Patients in the ER/RFA group underwent focal ER for visible lesions followed by serial RFA. Follow-up endoscopy with biopsies (four-quadrant/2 cm BO) was performed at 6 and 12 months and then annually. The main outcome measures were: stenosis rate; complications; complete histological response for neoplasia (CR-neoplasia); and complete histological response for intestinal metaplasia (CR-IM).
  
  
  RESULTS
  CR-neoplasia was achieved in 25/25 (100%) SRER and in 21/22 (96%) ER/RFA patients. CR-IM was achieved in 23 (92%) SRER and 21 (96%) ER/RFA patients. The stenosis rate was significantly higher in SRER (88%) versus ER/RFA (14%; p<0.001), resulting in more therapeutic sessions in SRER (6 vs 3; p<0.001) due to dilations. After median 24 months follow-up, one SRER patient had recurrence of EC, requiring ER.
  
  
  CONCLUSIONS
  In patients with BO ≤ 5 cm containing HGD/EC, SRER and ER/RFA achieved comparably high rates of CR-IM and CR-neoplasia. However, SRER was associated with a higher number of complications and therapeutic sessions. For these patients, a combined endoscopic approach of focal ER followed by RFA may thus be preferred over SRER. Clinical trial number NTR1337.
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Frederike G I
authors.initials: FG
authors.lastname: van Vilsteren
authors.forename: Roos E
authors.initials: RE
authors.lastname: Pouw
authors.forename: Stefan
authors.initials: S
authors.lastname: Seewald
authors.forename: Lorenza
authors.initials: L
authors.lastname: Alvarez Herrero
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: Karl C
authors.initials: KC
authors.lastname: Yu Kim Teng
authors.forename: Nib
authors.initials: N
authors.lastname: Soehendra
authors.forename: Thomas
authors.initials: T
authors.lastname: Rösch
authors.forename: Bas L A M
authors.initials: BL
authors.lastname: Weusten
authors.forename: Jacques J G H M
authors.initials: JJ
authors.lastname: Bergman
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D001471:Barrett Esophagus / Q000473:pathology / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods*; D004938:Esophageal Neoplasms / Q000473:pathology / Q000601:surgery*; D004940:Esophageal Stenosis / Q000209:etiology; D004945:Esophagoscopy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011230:Precancerous Conditions / Q000473:pathology / Q000601:surgery*; D011446:Prospective Studies; D012074:Remission Induction; D016896:Treatment Outcome