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In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia: a multicenter international randomized controlled trial (with video).
Gastrointest Endosc 2014; 79(2):211-21GE

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.).

Authors+Show Affiliations

Division of Gastroenterology, Department of Medicine, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.Mount Sinai Medical Center, New York, New York, USA.Harvard Medical School/Massachusetts General Hospital, Boston, Massachusetts, USA.University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.Dallas Veterans Affairs Medical Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.Division of Biostatistics and Bioinformatics, Department of Oncology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.Emory University School of Medicine/Emory University Hospital, Atlanta, Georgia, USA.Division of Gastroenterology, Department of Medicine, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.Johannes Guttenberg University, Mainz, Germany.Department of Anatomic Pathology, Cleveland Clinic Foundation, Cleveland, Ohio, USA.Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.Johannes Guttenberg University, Mainz, Germany.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Video-Audio Media

Language

eng

PubMed ID

24219822

Citation

Canto, Marcia Irene, et al. "In Vivo Endomicroscopy Improves Detection of Barrett's Esophagus-related Neoplasia: a Multicenter International Randomized Controlled Trial (with Video)." Gastrointestinal Endoscopy, vol. 79, no. 2, 2014, pp. 211-21.
Canto MI, Anandasabapathy S, Brugge W, et al. In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia: a multicenter international randomized controlled trial (with video). Gastrointest Endosc. 2014;79(2):211-21.
Canto, M. I., Anandasabapathy, S., Brugge, W., Falk, G. W., Dunbar, K. B., Zhang, Z., ... Kiesslich, R. (2014). In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia: a multicenter international randomized controlled trial (with video). Gastrointestinal Endoscopy, 79(2), pp. 211-21. doi:10.1016/j.gie.2013.09.020.
Canto MI, et al. In Vivo Endomicroscopy Improves Detection of Barrett's Esophagus-related Neoplasia: a Multicenter International Randomized Controlled Trial (with Video). Gastrointest Endosc. 2014;79(2):211-21. PubMed PMID: 24219822.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia: a multicenter international randomized controlled trial (with video). AU - Canto,Marcia Irene, AU - Anandasabapathy,Sharmila, AU - Brugge,William, AU - Falk,Gary W, AU - Dunbar,Kerry B, AU - Zhang,Zhe, AU - Woods,Kevin, AU - Almario,Jose Antonio, AU - Schell,Ursula, AU - Goldblum,John, AU - Maitra,Anirban, AU - Montgomery,Elizabeth, AU - Kiesslich,Ralf, AU - ,, Y1 - 2013/11/09/ PY - 2013/07/25/received PY - 2013/09/18/accepted PY - 2013/11/14/entrez PY - 2013/11/14/pubmed PY - 2014/10/1/medline KW - BE KW - Barrett's esophagus KW - CLE KW - CPT KW - Current Procedural Terminology KW - ECA KW - HDWLE KW - HGD KW - NBI KW - RB KW - TB KW - WLE KW - confocal laser endomicroscopy KW - eCLE KW - endoscope-based CLE KW - esophageal adenocarcinoma KW - high-definition white-light endoscopy KW - high-grade dysplasia KW - narrow-band imaging KW - pCLE KW - probe-based CLE KW - random biopsy KW - targeted biopsy KW - white-light endoscopy SP - 211 EP - 21 JF - Gastrointestinal endoscopy JO - Gastrointest. Endosc. VL - 79 IS - 2 N2 - 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.). SN - 1097-6779 UR - https://www.unboundmedicine.com/medline/citation/24219822/In_vivo_endomicroscopy_improves_detection_of_Barrett's_esophagus_related_neoplasia:_a_multicenter_international_randomized_controlled_trial__with_video__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5107(13)02405-X DB - PRIME DP - Unbound Medicine ER -