A prospective multicenter study using a new multiband mucosectomy device for endoscopic resection of early neoplasia in Barrett’s esophagus - 17/09/18
Abstract |
Background and Aims |
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.
Methods |
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.
Results |
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).
Conclusions |
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.)
Il testo completo di questo articolo è disponibile in PDF.Abbreviations : BE, CI, ER, HGD, IQR, MBM
Mappa
| DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: T. Beyna: Honoraria and consultant for Boston Scientific and Olympus; honoraria from Medtronic. A. Koch: Research support from Cook Medical and Interscope; speaker and consultant for Erbe Elektromedizin. E. Schoon: Speaker and consultant for Medtronic, Boston Scientific, and Olympus; research support from Fujifilm. R. Haidry: Research support from Cook Medical, Pentax Europe, Covidien/Medtronic, Beamline technologies, and C2 Therepeutics. B. Weusten: Research support from Covidien/Medtronic and C2Therapeutic. R. Bisschops: Speaker and consultant for Medtronic, Pentax, and Fujifilm; research support from Pentax, Fujifilm, and Cook Medical; consultant for Boston Scientific. N. Shaheen: Consultant for Boston Scientific, Medtronic, C2 Therapeutics, CSA Medical, CDx Medical, Interpace Diagnostics, and Cook Medical. M. Wallace: Consultant for Aries Pharmaceutical, Virgo Inc, and Lumendi Inc; research support from Boston Scientific, Medtronic, Fujifilm, Olympus, and ChiroChen; owner of Endoquality Consulting. K. Wang: Consultant for Boston Scientific. K. Ragunath: Education grants, research support, and consultant for Boston Scientific. M. DiPietro: Speaker for Medtronic, consultant for Boston Scientific. O. Pech: Speaker for Medtronic, Olympus, Fujifilm, Boston Scientific, Falk, AbbVie, Bristol Myers Squibb, and Creo Medical. H. Neuhaus: Speaker and consultant for Boston Scientific, Cook Medical, Erbe, and Olympus; speaker for Falk Foundation, Fujifilm, and Medtronic; research support from Boston Scientific, Cook Medical, CDx Diagnostics, Olympus, and Pentax. J. Bergman: Research support from Covidien/Medtronic, Olympus Endoscopy, Cook Medical, Boston Scientific, Erbe Medical, C2 Therapeutic, and Ninepoint Medical; consultant for Boston Scientific, Cook Medical, and Covidien/Medtronic. All other authors disclosed no financial relationships relevant to this publication. Research support for this study was provided by Boston Scientific. |
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| If you would like to chat with an author of this article, you may contact Dr Pouw at r.e.pouw@amc.uva.nl. |
Vol 88 - N° 4
P. 647-654 - ottobre 2018 Ritorno al numeroBenvenuto su EM|consulte, il riferimento dei professionisti della salute.
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