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


METHODS
Multicenter, randomized, controlled trial.


METHODS
Academic medical centers.


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


METHODS
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.


METHODS
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.


CONCLUSIONS
Tertiary-care referral centers and expert endoscopists limit generalizability.


CONCLUSIONS
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. (


BACKGROUND
NCT01124214.).
Division of Gastroenterology, Department of Medicine, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
Marcia Irene
MI
Canto
Mount Sinai Medical Center, New York, New York, USA.
Sharmila
S
Anandasabapathy
Harvard Medical School/Massachusetts General Hospital, Boston, Massachusetts, USA.
William
W
Brugge
University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Gary W
GW
Falk
Dallas Veterans Affairs Medical Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Kerry B
KB
Dunbar
Division of Biostatistics and Bioinformatics, Department of Oncology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
Zhe
Z
Zhang
Emory University School of Medicine/Emory University Hospital, Atlanta, Georgia, USA.
Kevin
K
Woods
Division of Gastroenterology, Department of Medicine, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
Jose Antonio
JA
Almario
Johannes Guttenberg University, Mainz, Germany.
Ursula
U
Schell
Department of Anatomic Pathology, Cleveland Clinic Foundation, Cleveland, Ohio, USA.
John
J
Goldblum
Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
Anirban
A
Maitra
Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
Elizabeth
E
Montgomery
Johannes Guttenberg University, Mainz, Germany.
Ralf
R
Kiesslich
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001471:Barrett Esophagus / Q000150:complications / Q000473:pathology*; D001706:Biopsy; D004938:Esophageal Neoplasms / Q000175:diagnosis* / Q000209:etiology; D004945:Esophagoscopy / Q000379:methods*; D004947:Esophagus / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D008297:Male; D018613:Microscopy, Confocal; D008875:Middle Aged; D011446:Prospective Studies; D015203:Reproducibility of Results; D016037:Single-Blind Method
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