Sharma, PrateekMeining, Alexander R.Coron, EmmanuelLightdale, Charles J.Wolfsen, Herbert C.Bansal, AjayBajbouj, MontherGalmiche, Jean-PaulAbrams, Julian A.Rastogi, AmitGupta, NeilMichalek, Joel E.Lauwers, Gregory Y.Wallace, Michael B.2014-07-292011Sharma, Prateek, Alexander R. Meining, Emmanuel Coron, Charles J. Lightdale, Herbert C. Wolfsen, Ajay Bansal, Monther Bajbouj, et al. 2011. 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. Gastrointestinal Endoscopy 74(3): 465–472.0016-5107http://nrs.harvard.edu/urn-3:HUL.InstRepos:12605309BACKGROUND: 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. DESIGN: International, prospective, multicenter, randomized, controlled trial. SETTING: Five tertiary referral centers. PATIENTS: A total of 101 consecutive BE patients presenting for surveillance or endoscopic treatment of HGD/EC. INTERVENTIONS: 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. MAIN OUTCOME MEASUREMENTS: 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. LIMITATIONS: 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. (Clinical trial registration number: NCT00795184.).en-USJournal Article2014-07-2910.1016/j.gie.2011.04.004