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Randomized Controlled Trial
. 2011 Sep;74(3):465-72.
doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13.

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

Prateek Sharma  1 , Alexander R Meining, Emmanuel Coron, Charles J Lightdale, Herbert C Wolfsen, Ajay Bansal, Monther Bajbouj, Jean-Paul Galmiche, Julian A Abrams, Amit Rastogi, Neil Gupta, Joel E Michalek, Gregory Y Lauwers, Michael B Wallace
Affiliations
Randomized Controlled Trial

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

Prateek Sharma et al. Gastrointest Endosc. 2011 Sep.

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.

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.).

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Figures

Figure 1
Figure 1
Study design and flow chart. BE, Barrett’s esophagus; HD-WLE, high-definition white-light endoscopy; NBI, narrow-band imaging; pCLE, probe-based confocal laser endomicroscopy.
Figure 2
Figure 2
Probe-based confocal laser endomicroscopy images showing nondysplastic Barrett’s esophagus (BE) (A) and BE with early esophageal adenocarcinoma (B).
See this image and copyright information in PMC

Comment in

References

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