title: Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus.
abstract: BACKGROUND
  Endoscopic ablation is an accepted standard for neoplasia in Barrett's esophagus (BE). Eradication of all glandular mucosa in the distal esophagus cannot be reliably determined at endoscopy.
  
  
  OBJECTIVE
  To assess if use of probe-based confocal laser endomicroscopy (pCLE) in addition to high-definition white light (HDWL) could aid in determination of residual BE.
  
  
  METHODS
  Prospective, multicenter, randomized, clinical trial.
  
  
  METHODS
  Academic medical centers.
  
  
  METHODS
  Patients with Barrett's esophagus undergoing ablation.
  
  
  METHODS
  After an initial attempt at ablation, patients were followed-up either with HDWL endoscopy or HDWL plus pCLE, with treatment of residual metaplasia or neoplasia based on endoscopic findings and pCLE used to avoid overtreatment.
  
  
  METHODS
  The proportion of optimally treated patients, defined as those with residual BE who were treated and had complete ablation plus those without BE who were not treated and had no evidence of disease at follow-up.
  
  
  RESULTS
  The study was halted at the planned interim analysis based on a priori criteria. After enrollment was halted, all patients who had been randomized were followed to study completion. Among the 119 patients with follow-up, there was no difference in the proportion of patients achieving optimal outcomes in the two groups (15/57, 26% for HDWL; 17/62, 27% with HDWL + pCLE). Other outcomes were similar in the two groups.
  
  
  CONCLUSIONS
  The study was closed after the interim analysis due to low conditional power resulting from lack of difference between groups as well as higher-than-expected residual Barrett's esophagus in both arms.
  
  
  CONCLUSIONS
  This study yields no evidence that the addition of pCLE to HDWL imaging for detection of residual Barrett's esophagus or neoplasia can provide improved treatment.
authors: Mayo Clinic, Jacksonville, Florida, USA. Wallace.michael@mayo.edu
authors: Michael B
authors: MB
authors: Wallace
authors: Julia E
authors: JE
authors: Crook
authors: Michael
authors: M
authors: Saunders
authors: Laurence
authors: L
authors: Lovat
authors: Emmanuel
authors: E
authors: Coron
authors: Irving
authors: I
authors: Waxman
authors: Prateek
authors: P
authors: Sharma
authors: Joo H
authors: JH
authors: Hwang
authors: Matthew
authors: M
authors: Banks
authors: Mathieu
authors: M
authors: DePreville
authors: Jean P
authors: JP
authors: Galmiche
authors: Vani
authors: V
authors: Konda
authors: Nancy N
authors: NN
authors: Diehl
authors: Herbert C
authors: HC
authors: Wolfsen
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology* / Q000601:surgery; D000368:Aged; D000369:Aged, 80 and over; D001471:Barrett Esophagus / Q000473:pathology* / Q000601:surgery; D001706:Biopsy; D004938:Esophageal Neoplasms / Q000473:pathology* / Q000601:surgery; D004945:Esophagoscopy / Q000379:methods*; D004947:Esophagus / Q000473:pathology*; D005260:Female; D006801:Humans; D008297:Male; D008679:Metaplasia / Q000473:pathology; D018613:Microscopy, Confocal; D008875:Middle Aged; D009092:Mucous Membrane / Q000473:pathology / Q000601:surgery; D018365:Neoplasm, Residual