In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia

A multicenter international randomized controlled trial (with video)

Marcia Irene Canto, Sharmila Anandasabapathy, William Brugge, Gary W. Falk, Kerry B. Dunbar, Zhe Zhang, Kevin Woods, Jose Antonio Almario, Ursula Schell, John Goldblum, Anirban Maitra, Elizabeth Montgomery, Ralf Kiesslich

Research output: Contribution to journalArticle

114 Citations (Scopus)

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.).

Original languageEnglish (US)
Pages (from-to)211-221
Number of pages11
JournalGastrointestinal Endoscopy
Volume79
Issue number2
DOIs
StatePublished - Feb 2014

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Barrett Esophagus
Endoscopy
Endoscopes
Randomized Controlled Trials
Biopsy
Light
Neoplasms
Lasers
Tertiary Care Centers
Time Management
Gastrointestinal Tract
Decision Making
Mucous Membrane
Clinical Trials
Pathology

ASJC Scopus subject areas

  • Gastroenterology
  • Radiology Nuclear Medicine and imaging

Cite this

In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia : A multicenter international randomized controlled trial (with video). / Canto, Marcia Irene; Anandasabapathy, Sharmila; Brugge, William; Falk, Gary W.; Dunbar, Kerry B.; Zhang, Zhe; Woods, Kevin; Almario, Jose Antonio; Schell, Ursula; Goldblum, John; Maitra, Anirban; Montgomery, Elizabeth; Kiesslich, Ralf.

In: Gastrointestinal Endoscopy, Vol. 79, No. 2, 02.2014, p. 211-221.

Research output: Contribution to journalArticle

Canto, MI, Anandasabapathy, S, Brugge, W, Falk, GW, Dunbar, KB, Zhang, Z, Woods, K, Almario, JA, Schell, U, Goldblum, J, Maitra, A, Montgomery, E & Kiesslich, R 2014, '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, pp. 211-221. https://doi.org/10.1016/j.gie.2013.09.020
Canto, Marcia Irene ; Anandasabapathy, Sharmila ; Brugge, William ; Falk, Gary W. ; Dunbar, Kerry B. ; Zhang, Zhe ; Woods, Kevin ; Almario, Jose Antonio ; Schell, Ursula ; Goldblum, John ; Maitra, Anirban ; Montgomery, Elizabeth ; Kiesslich, Ralf. / In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia : A multicenter international randomized controlled trial (with video). In: Gastrointestinal Endoscopy. 2014 ; Vol. 79, No. 2. pp. 211-221.
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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.).",
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AU - Brugge, William

AU - Falk, Gary W.

AU - Dunbar, Kerry B.

AU - Zhang, Zhe

AU - Woods, Kevin

AU - Almario, Jose Antonio

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AU - Maitra, Anirban

AU - Montgomery, Elizabeth

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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.).

AB - 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.).

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