title: Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial.
abstract: BACKGROUND
  Probe-based confocal laser endomicroscopy (pCLE) allows real-time detection of neoplastic Barrett's esophagus (BE) tissue. However, the accuracy of pCLE in real time has not yet been extensively evaluated.
  
  
  OBJECTIVE
  To compare the sensitivity and specificity of pCLE in addition to high-definition white-light endoscopy (HD-WLE) with HD-WLE alone for the detection of high-grade dysplasia (HGD) and early carcinoma (EC) in BE.
  
  
  METHODS
  International, prospective, multicenter, randomized, controlled trial.
  
  
  METHODS
  Five tertiary referral centers.
  
  
  METHODS
  A total of 101 consecutive BE patients presenting for surveillance or endoscopic treatment of HGD/EC.
  
  
  METHODS
  All patients were examined by HD-WLE, narrow-band imaging (NBI), and pCLE, and the findings were recorded before biopsy samples were obtained. The order of HD-WLE and NBI was randomized and performed by 2 independent, blinded endoscopists. All suspicious lesions on HD-WLE or NBI and 4-quadrant random locations were documented. These locations were examined by pCLE, and a presumptive diagnosis of benign or neoplastic (HGD/EC) tissue was made in real time. Finally, biopsies were taken from all locations and were reviewed by a central pathologist, blinded to endoscopic and pCLE data.
  
  
  METHODS
  Diagnostic characteristics of pCLE.
  
  
  RESULTS
  The sensitivity and specificity for HD-WLE were 34.2% and 92.7%, respectively, compared with 68.3% and 87.8%, respectively, for HD-WLE or pCLE (P = .002 and P < .001, respectively). The sensitivity and specificity for HD-WLE or NBI were 45.0% and 88.2%, respectively, compared with 75.8% and 84.2%, respectively, for HD-WLE, NBI, or pCLE (P = .01 and P = .02, respectively). Use of pCLE in conjunction with HD-WLE and NBI enabled the identification of 2 and 1 additional HGD/EC patients compared with HD-WLE and HD-WLE or NBI, respectively, resulting in detection of all HGD/EC patients, although not statistically significant.
  
  
  CONCLUSIONS
  Academic centers with enriched population.
  
  
  CONCLUSIONS
  pCLE combined with HD-WLE significantly improved the ability to detect neoplasia in BE patients compared with HD-WLE. This may allow better informed decisions to be made for the management and subsequent treatment of BE patients. (
  
  
  BACKGROUND
  NCT00795184.).
authors: Veterans Affairs Medical Center and University of Kansas School of Medicine, Kansas City, Missouri, USA. psharma@kumc.edu
authors: Prateek
authors: P
authors: Sharma
authors: Alexander R
authors: AR
authors: Meining
authors: Emmanuel
authors: E
authors: Coron
authors: Charles J
authors: CJ
authors: Lightdale
authors: Herbert C
authors: HC
authors: Wolfsen
authors: Ajay
authors: A
authors: Bansal
authors: Monther
authors: M
authors: Bajbouj
authors: Jean-Paul
authors: JP
authors: Galmiche
authors: Julian A
authors: JA
authors: Abrams
authors: Amit
authors: A
authors: Rastogi
authors: Neil
authors: N
authors: Gupta
authors: Joel E
authors: JE
authors: Michalek
authors: Gregory Y
authors: GY
authors: Lauwers
authors: Michael B
authors: MB
authors: Wallace
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001471:Barrett Esophagus / Q000473:pathology*; D002277:Carcinoma / Q000175:diagnosis*; D004938:Esophageal Neoplasms / Q000175:diagnosis*; D004945:Esophagoscopy / Q000379:methods; D005260:Female; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D008027:Light; D008297:Male; D018613:Microscopy, Confocal; D008875:Middle Aged; D011230:Precancerous Conditions / Q000473:pathology*; D012680:Sensitivity and Specificity; D016037:Single-Blind Method; D013997:Time Factors