title: A randomised trial of endoscopic submucosal dissection versus endoscopic mucosal resection for early Barrett's neoplasia.
abstract: For endoscopic resection of early GI neoplasia, endoscopic submucosal dissection (ESD) achieves higher rates of complete resection (R0) than endoscopic mucosal resection (EMR). However, ESD is technically more difficult and evidence from randomised trial is missing.
  
  
  
  We compared the efficacy and safety of ESD and EMR in patients with neoplastic Barrett's oesophagus (BO).
  
  
  
  BO patients with a focal lesion of high-grade intraepithelial neoplasia (HGIN) or early adenocarcinoma (EAC) ≤3 cm were randomised to either ESD or EMR. Primary outcome was R0 resection; secondary outcomes were complete remission from neoplasia, recurrences and adverse events (AEs).
  
  
  
  There were no significant differences in patient and lesion characteristics between the groups randomised to ESD (n=20) or EMR (n=20). Histology of the resected specimen showed HGIN or EAC in all but six cases. Although R0 resection defined as margins free of HGIN/EAC was achieved more frequently with ESD (10/17 vs 2/17, p=0.01), there was no difference in complete remission from neoplasia at 3 months (ESD 15/16 vs EMR 16/17, p=1.0). During a mean follow-up period of 23.1±6.4 months, recurrent EAC was observed in one case in the ESD group. Elective surgery was performed in four and three cases after ESD and EMR, respectively (p=1.0). Two severe AEs were recorded for ESD and none for EMR (p=0.49).
  
  
  
  In terms of need for surgery, neoplasia remission and recurrence, ESD and EMR are both highly effective for endoscopic resection of early BO neoplasia. ESD achieves a higher R0 resection rate, but for most BO patients this bears little clinical relevance. ESD is, however, more time consuming and may cause severe AE.
  
  
  
  NCT1871636.
authors.affiliation: GastroPraxis Köln-Nord, Schwerpunktpraxis für Gastroenterologie und Hepatologie Köln, Cologne, Germany.
authors.forename: Grischa
authors.initials: G
authors.lastname: Terheggen
authors.affiliation: Department of Gastroenterology, Evangelisches Krankenhaus Düsseldorf, Düssseldorf, Germany.
authors.forename: Eva Maria
authors.initials: EM
authors.lastname: Horn
authors.affiliation: Institute of Pathology, Klinikum Bayreuth, Bayreuth, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Vieth
authors.affiliation: Institute of Pathology, University of Düsseldorf, Düssseldorf, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Gabbert
authors.affiliation: ERBE Elektromedizin GmbH, Tübingen, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Enderle
authors.affiliation: ERBE Elektromedizin GmbH, Tübingen, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Neugebauer
authors.affiliation: Klinik für Innere Medizin und Gastroenterologie, Elisabeth Krankenhaus Essen, Essen, Germany.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Schumacher
authors.affiliation: Department of Gastroenterology, Evangelisches Krankenhaus Düsseldorf, Düssseldorf, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Neuhaus
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D000368:Aged; D001471:Barrett Esophagus / Q000473:pathology / Q000601:surgery*; D002278:Carcinoma in Situ / Q000473:pathology / Q000601:surgery*; D000069916:Endoscopic Mucosal Resection / Q000009:adverse effects* / Q000379:methods*; D004938:Esophageal Neoplasms / Q000473:pathology / Q000601:surgery*; D016629:Esophagectomy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D000072662:Margins of Excision; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology; D018365:Neoplasm, Residual; D011446:Prospective Studies; D012086:Reoperation
keywords: BARRETT’S OESOPHAGUS; ENDOSCOPIC PROCEDURES; ENDOSCOPY