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Gastrointest Endosc. 2014 Feb;79(2):211-21. doi: 10.1016/j.gie.2013.09.020. Epub 2013 Nov 9.

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

Author information

1
Division of Gastroenterology, Department of Medicine, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
2
Mount Sinai Medical Center, New York, New York, USA.
3
Harvard Medical School/Massachusetts General Hospital, Boston, Massachusetts, USA.
4
University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
5
Dallas Veterans Affairs Medical Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
6
Division of Biostatistics and Bioinformatics, Department of Oncology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
7
Emory University School of Medicine/Emory University Hospital, Atlanta, Georgia, USA.
8
Johannes Guttenberg University, Mainz, Germany.
9
Department of Anatomic Pathology, Cleveland Clinic Foundation, Cleveland, Ohio, USA.
10
Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.

Abstract

BACKGROUND:

Confocal laser endomicroscopy (CLE) enables in 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 + 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 + RB (group 1) or HDWLE + eCLE + 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 + eCLE + TB led to a lower number of mucosal biopsies and higher diagnostic yield for neoplasia (34% vs 7%; P < .0001), compared with HDWLE + RB but with comparable accuracy. HDWLE + eCLE + TB tripled the diagnostic yield for neoplasia (22% vs 6%; P = .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 < .0001) without significant reduction in specificity. In 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 vivo decision making by altering the diagnosis and guiding therapy. (

CLINICAL TRIAL REGISTRATION NUMBER:

NCT01124214.).

KEYWORDS:

BE; Barrett's esophagus; CLE; CPT; Current Procedural Terminology; ECA; HDWLE; HGD; NBI; RB; TB; WLE; confocal laser endomicroscopy; eCLE; endoscope-based CLE; esophageal adenocarcinoma; high-definition white-light endoscopy; high-grade dysplasia; narrow-band imaging; pCLE; probe-based CLE; random biopsy; targeted biopsy; white-light endoscopy

PMID:
24219822
PMCID:
PMC4668117
DOI:
10.1016/j.gie.2013.09.020
[Indexed for MEDLINE]
Free PMC Article

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