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

K Belghazi; D W Schölvinck; M I van Berge Henegouwen; S S Gisbertz; B L Weusten; S L Meijer; J J Bergman; R E Pouw

doi:https://doi.org/10.1007/s00464-018-6582-5

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

K Belghazi, D W Schölvinck, M I van Berge Henegouwen, S S Gisbertz, B L Weusten, S L Meijer, J J Bergman, R E Pouw

Research output: Contribution to journal › Article › Academic › peer-review

4 Citations (Scopus)

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.

Original language	English
Pages (from-to)	2864-2872
Number of pages	9
Journal	Surgical endoscopy
Volume	33
Issue number	9
DOIs	https://doi.org/10.1007/s00464-018-6582-5
Publication status	Published - Sept 2019

Keywords

Adolescent
Adult
Aged
Aged, 80 and over
Barrett Esophagus/diagnosis
Endoscopic Mucosal Resection/instrumentation
Endosonography
Equipment Design
Esophagectomy/methods
Esophagoscopy/methods
Female
Humans
Male
Middle Aged
Pilot Projects
Tomography, X-Ray Computed
Young Adult

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https://doi.org/10.1007/s00464-018-6582-5

Cite this

Belghazi, K., Schölvinck, D. W., van Berge Henegouwen, M. I., Gisbertz, S. S., Weusten, B. L., Meijer, S. L., Bergman, J. J., & Pouw, R. E. (2019). 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. Surgical endoscopy, 33(9), 2864-2872. https://doi.org/10.1007/s00464-018-6582-5

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title = "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.",

keywords = "Adolescent, Adult, Aged, Aged, 80 and over, Barrett Esophagus/diagnosis, Endoscopic Mucosal Resection/instrumentation, Endosonography, Equipment Design, Esophagectomy/methods, Esophagoscopy/methods, Female, Humans, Male, Middle Aged, Pilot Projects, Tomography, X-Ray Computed, Young Adult",

author = "K Belghazi and Sch{\"o}lvinck, {D W} and {van Berge Henegouwen}, {M I} and Gisbertz, {S S} and Weusten, {B L} and Meijer, {S L} and Bergman, {J J} and Pouw, {R E}",

year = "2019",

month = sep,

doi = "https://doi.org/10.1007/s00464-018-6582-5",

language = "English",

volume = "33",

pages = "2864--2872",

journal = "Surgical endoscopy",

issn = "0930-2794",

publisher = "Springer New York",

number = "9",

}

Belghazi, K, Schölvinck, DW, van Berge Henegouwen, MI , Gisbertz, SS, Weusten, BL, Meijer, SL, Bergman, JJ & Pouw, RE 2019, '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', Surgical endoscopy, vol. 33, no. 9, pp. 2864-2872. https://doi.org/10.1007/s00464-018-6582-5

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; Schölvinck, D W; van Berge Henegouwen, M I et al.
In: Surgical endoscopy, Vol. 33, No. 9, 09.2019, p. 2864-2872.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Results of a two-phased clinical study evaluating a new multiband mucosectomy device for early Barrett's neoplasia

T2 - a randomized pre-esophagectomy trial and a pilot therapeutic pilot study

AU - Belghazi, K

AU - Schölvinck, D W

AU - van Berge Henegouwen, M I

AU - Gisbertz, S S

AU - Weusten, B L

AU - Meijer, S L

AU - Bergman, J J

AU - Pouw, R E

PY - 2019/9

Y1 - 2019/9

N2 - 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.

AB - 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.

KW - Adolescent

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Barrett Esophagus/diagnosis

KW - Endoscopic Mucosal Resection/instrumentation

KW - Endosonography

KW - Equipment Design

KW - Esophagectomy/methods

KW - Esophagoscopy/methods

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Pilot Projects

KW - Tomography, X-Ray Computed

KW - Young Adult

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UR - https://www.ncbi.nlm.nih.gov/pubmed/30456511

U2 - https://doi.org/10.1007/s00464-018-6582-5

DO - https://doi.org/10.1007/s00464-018-6582-5

M3 - Article

C2 - 30456511

SN - 0930-2794

VL - 33

SP - 2864

EP - 2872

JO - Surgical endoscopy

JF - Surgical endoscopy

IS - 9

ER -

Belghazi K, Schölvinck DW, van Berge Henegouwen MI , Gisbertz SS, Weusten BL, Meijer SL et al. 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. Surgical endoscopy. 2019 Sept;33(9):2864-2872. doi: https://doi.org/10.1007/s00464-018-6582-5

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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