A prospective multicenter study using a new multiband mucosectomy device for endoscopic resection of early neoplasia in Barrett’s esophagus

Early neoplasia in Barrett’s esophagus (BE) can be effectively and safely removed by endoscopic resection (ER) using multiband mucosectomy (MBM). This study aimed to document performance of a novel MBM device designed for improved visualization, easier passage of accessories, and better suction powe...

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Veröffentlicht in:Gastrointestinal endoscopy 2018-10, Vol.88 (4), p.647-654
Hauptverfasser: Pouw, Roos E., Beyna, Torsten, Belghazi, Kamar, Koch, Arjun D., Schoon, Erik J., Haidry, Rehan, Weusten, Bas L., Bisschops, Raf, Shaheen, Nicholas J., Wallace, Michael B., Marcon, Norman, Heise-Ginsburg, Rachel, Gotink, Anniek W., Wang, Kenneth K., Leggett, Cadman L., Ortiz-Fernández-Sordo, Jacobo, Ragunath, Krish, DiPietro, Massimiliano, Pech, Oliver, Neuhaus, Horst, Bergman, Jacques J.
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container_end_page 654
container_issue 4
container_start_page 647
container_title Gastrointestinal endoscopy
container_volume 88
creator Pouw, Roos E.
Beyna, Torsten
Belghazi, Kamar
Koch, Arjun D.
Schoon, Erik J.
Haidry, Rehan
Weusten, Bas L.
Bisschops, Raf
Shaheen, Nicholas J.
Wallace, Michael B.
Marcon, Norman
Heise-Ginsburg, Rachel
Gotink, Anniek W.
Wang, Kenneth K.
Leggett, Cadman L.
Ortiz-Fernández-Sordo, Jacobo
Ragunath, Krish
DiPietro, Massimiliano
Pech, Oliver
Neuhaus, Horst
Bergman, Jacques J.
description Early neoplasia in Barrett’s esophagus (BE) can be effectively and safely removed by endoscopic resection (ER) using multiband mucosectomy (MBM). This study aimed to document performance of a novel MBM device designed for improved visualization, easier passage of accessories, and better suction power compared with other marketed MBM devices. This international, single-arm, prospective registry in 14 referral centers (Europe, 10; United States, 3; Canada, 1) included patients with early BE neoplasia scheduled for ER. The primary endpoint was successful ER defined as complete resection of the delineated area in 1 procedure. Secondary outcomes were adverse events and procedure time. A total of 332 lesions was included in 291 patients (248 men; mean age, 67 years [standard deviation, 9.6]). ER indication was high-grade dysplasia in 64%, early adenocarcinoma in 19%, lesion with low-grade dysplasia in 11%, and a lesion without definite histology in 6%. Successful ER was reached in 322 of 332 lesions (97%; 95% confidence interval [CI], 94.6%-98.4%). A perforation occurred in 3 of 332 procedures (.9%; 95% CI, .31%-2.62%), all were managed endoscopically, and patients were admitted with intravenous antibiotics during days 2, 3, and 9. Postprocedural bleeding requiring an intervention occurred in 5 of 332 resections (1.5%; 95% CI, .65%-3.48%). Dysphagia requiring dilatation occurred in 11 patients (3.8%; 95% CI, 2.1%-6.6%). Median procedure time was 16 minutes (interquartile range, 12.0-26.0). In expert hands, the novel MBM device proved to be effective for resection of early neoplastic lesions in BE, with successful ER in 97% of procedures. Severe adverse events were rare and were effectively managed endoscopically or conservatively. (Clinical trial registration number: NCT02482701.)
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This study aimed to document performance of a novel MBM device designed for improved visualization, easier passage of accessories, and better suction power compared with other marketed MBM devices. This international, single-arm, prospective registry in 14 referral centers (Europe, 10; United States, 3; Canada, 1) included patients with early BE neoplasia scheduled for ER. The primary endpoint was successful ER defined as complete resection of the delineated area in 1 procedure. Secondary outcomes were adverse events and procedure time. A total of 332 lesions was included in 291 patients (248 men; mean age, 67 years [standard deviation, 9.6]). ER indication was high-grade dysplasia in 64%, early adenocarcinoma in 19%, lesion with low-grade dysplasia in 11%, and a lesion without definite histology in 6%. Successful ER was reached in 322 of 332 lesions (97%; 95% confidence interval [CI], 94.6%-98.4%). A perforation occurred in 3 of 332 procedures (.9%; 95% CI, .31%-2.62%), all were managed endoscopically, and patients were admitted with intravenous antibiotics during days 2, 3, and 9. Postprocedural bleeding requiring an intervention occurred in 5 of 332 resections (1.5%; 95% CI, .65%-3.48%). Dysphagia requiring dilatation occurred in 11 patients (3.8%; 95% CI, 2.1%-6.6%). Median procedure time was 16 minutes (interquartile range, 12.0-26.0). In expert hands, the novel MBM device proved to be effective for resection of early neoplastic lesions in BE, with successful ER in 97% of procedures. Severe adverse events were rare and were effectively managed endoscopically or conservatively. 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subjects Adenocarcinoma - diagnostic imaging
Adenocarcinoma - surgery
Aged
Barrett Esophagus - diagnostic imaging
Barrett Esophagus - pathology
Barrett Esophagus - surgery
Deglutition Disorders - etiology
Endoscopic Mucosal Resection - adverse effects
Endoscopic Mucosal Resection - instrumentation
Esophageal Neoplasms - diagnostic imaging
Esophageal Neoplasms - surgery
Esophageal Perforation - etiology
Esophageal Perforation - surgery
Esophagoscopy
Female
Humans
Male
Middle Aged
Operative Time
Postoperative Hemorrhage - etiology
Postoperative Hemorrhage - surgery
Prospective Studies
Suction
title A prospective multicenter study using a new multiband mucosectomy device for endoscopic resection of early neoplasia in Barrett’s esophagus
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