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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Bibliographic Details
Published in:	Gastrointestinal endoscopy 2018-10, Vol.88 (4), p.647-654
Main Authors:	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.
Format:	Article
Language:	eng
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
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Summary:	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.)
ISSN:	0016-5107 1097-6779