In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia: a multicenter international randomized controlled trial (with video)
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Background

Confocal laser endomicroscopy (CLE) enables in聽vivo microscopic imaging of the GI tract mucosa. However, there are limited data on endoscope-based CLE (eCLE) for imaging Barrett's esophagus (BE).

Objective

To compare high-definition white-light endoscopy (HDWLE) alone with random biopsy (RB) and HDWLE聽+ eCLE and targeted biopsy (TB) for diagnosis of BE neoplasia.

Design

Multicenter, randomized, controlled trial.

Setting

Academic medical centers.

Patients

Adult patients with BE undergoing routine surveillance or referred for early neoplasia.

Intervention

Patients were randomized to HDWLE聽+ RB (group 1) or HDWLE聽+ eCLE聽+ TB (group 2). Real-time diagnoses and management plans were recorded after HDWLE in both groups and after eCLE in group 2. Blinded expert pathology diagnosis was the reference standard.

Main Outcome Measurements

Diagnostic yield, performance characteristics, clinical impact.

Results

A total of 192 patients with BE were studied. HDWLE聽+ eCLE聽+ TB led to a lower number of mucosal biopsies and higher diagnostic yield for neoplasia (34% vs 7%; P聽< .0001), compared with HDWLE聽+ RB but with comparable accuracy. HDWLE聽+ eCLE聽+ TB tripled the diagnostic yield for neoplasia (22% vs 6%; P聽= .002) and would have obviated the need for any biopsy in 65% of patients. The addition of eCLE to HDWLE increased the sensitivity for neoplasia detection to 96% from 40% (P聽< .0001) without significant reduction in specificity. In聽vivo CLE changed the treatment plan in 36% of patients.

Limitations

Tertiary-care referral centers and expert endoscopists limit generalizability.

Conclusion

Real-time eCLE and TB after HDWLE can improve the diagnostic yield and accuracy for neoplasia and significantly impact in聽vivo decision making by altering the diagnosis and guiding therapy. (Clinical trial registration number: .)

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