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Results of a two-phased clinical study evaluating a new multiband mucosectomy device for early Barrett's neoplasia: a randomized pre-esophagectomy trial and a pilot therapeutic pilot study.

ABSTRACT: BACKGROUND:Multiband mucosectomy (MBM) is the preferred technique for piecemeal resection of early neoplastic lesions in Barrett's esophagus (BE). The currently most widely used device for MBM is the Duette device. Recently, the Captivator EMR device has come available which might have practical advantages over the Duette device. METHODS:Phase I was a randomized pre-esophagectomy trial with a non-inferiority design aiming to compare EMR specimens obtained with the Captivator and the Duette device. PRIMARY OUTCOME:max diameter of the EMR specimens, secondary outcomes: min diameter, max thickness of the EMR specimens and resected submucosal stroma. Phase II were clinical pilot cases aiming to evaluate the feasibility of EMR using the Captivator device. Primary outcome was the successful EMR rate and secondary outcomes included procedure time and adverse events. RESULTS:Phase I: 24 EMR specimens (12 pairs) were obtained from six patients. The median max diameter of EMR specimens obtained with the Captivator device was 16 mm [IQR 12-21] versus 18 mm [IQR 13-23] for the Duette device. Non-inferiority of the max diameter of the Captivator specimens could not be demonstrated (median difference 1 mm, 95% CI -?3.26 to +?5.26). However, when using paired analysis, no significant difference was found (p 0.573). In addition, no statistically significant differences were found in the min diameter, max thickness of EMR specimens, and max thickness of resected submucosal stroma. Phase II: 5 BE patients with early neoplastic lesions were included. Successful EMR was achieved in 100%. Median procedure time was 33 min (IQR 25-39). One patient developed transient dysphagia, without signs of stenosis on endoscopy. CONCLUSIONS:EMR of early Barrett's neoplasia using the Captivator device is comparable to Duette EMR when looking at size of resected specimens. In the first patients, EMR using the Captivator was feasible, resulting in successful resection without acute adverse events.

SUBMITTER: Belghazi K

PROVIDER: S-EPMC6684496 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Results of a two-phased clinical study evaluating a new multiband mucosectomy device for early Barrett's neoplasia: a randomized pre-esophagectomy trial and a pilot therapeutic pilot study.

Belghazi K K Schölvinck D W DW van Berge Henegouwen M I MI Gisbertz S S SS Weusten B L BL Meijer S L SL Bergman J J JJ Pouw R E RE

Surgical endoscopy 20181119 9

<h4>Background</h4>Multiband mucosectomy (MBM) is the preferred technique for piecemeal resection of early neoplastic lesions in Barrett's esophagus (BE). The currently most widely used device for MBM is the Duette device. Recently, the Captivator EMR device has come available which might have practical advantages over the Duette device.<h4>Methods</h4>Phase I was a randomized pre-esophagectomy trial with a non-inferiority design aiming to compare EMR specimens obtained with the Captivator and t ...[more]

PMID: 30456511

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Project description:Early detection of esophageal neoplasia enables curative endoscopic therapy, but the current diagnostic standard of care has low sensitivity because early neoplasia is often inconspicuous with conventional white-light endoscopy. Here, we hypothesized that spectral endoscopy could enhance contrast for neoplasia in surveillance of patients with Barrett's esophagus. A custom spectral endoscope was deployed in a pilot clinical study of 20 patients to capture 715 in vivo tissue spectra matched with gold standard diagnosis from histopathology. Spectral endoscopy was sensitive to changes in neovascularization during the progression of disease; both non-dysplastic and neoplastic Barrett's esophagus showed higher blood volume relative to healthy squamous tissue (P = 0.001 and 0.02, respectively), and vessel radius appeared larger in neoplasia relative to non-dysplastic Barrett's esophagus (P = 0.06). We further developed a deep learning algorithm capable of classifying spectra of neoplasia versus non-dysplastic Barrett's esophagus with high accuracy (84.8% accuracy, 83.7% sensitivity, 85.5% specificity, 78.3% positive predictive value, and 89.4% negative predictive value). Exploiting the newly acquired library of labeled spectra to model custom color filter sets identified a potential 12-fold enhancement in contrast between neoplasia and non-dysplastic Barrett's esophagus using application-specific color filters compared with standard-of-care white-light imaging (perceptible color difference = 32.4 and 2.7, respectively). This work demonstrates the potential of endoscopic spectral imaging to extract vascular properties in Barrett's esophagus, to classify disease stages using deep learning, and to enable high-contrast endoscopy. SIGNIFICANCE: The results of this pilot first-in-human clinical trial demonstrate the potential of spectral endoscopy to reveal disease-associated vascular changes and to provide high-contrast delineation of neoplasia in the esophagus. GRAPHICAL ABSTRACT: http://cancerres.aacrjournals.org/content/canres/81/12/3415/F1.large.jpg.

Dataset Information

Results of a two-phased clinical study evaluating a new multiband mucosectomy device for early Barrett's neoplasia: a randomized pre-esophagectomy trial and a pilot therapeutic pilot study.

Publications

Results of a two-phased clinical study evaluating a new multiband mucosectomy device for early Barrett's neoplasia: a randomized pre-esophagectomy trial and a pilot therapeutic pilot study.

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