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A prospective multicenter study using a new multiband mucosectomy device for endoscopic resection of early neoplasia in Barrett’s esophagus - 17/09/18

Doi : 10.1016/j.gie.2018.06.030 
Roos E. Pouw, MD, PhD 1, , Torsten Beyna, MD, PhD 2, Kamar Belghazi, MD 1, Arjun D. Koch, MD, PhD 3, Erik J. Schoon, MD, PhD 4, Rehan Haidry, MD, PhD 5, Bas L. Weusten, MD, PhD 6, Raf Bisschops, MD, PhD 7, Nicholas J. Shaheen, MD, PhD 8, Michael B. Wallace, MD, PhD 9, Norman Marcon, MD, PhD 10, Rachel Heise-Ginsburg, MD, PhD 2, Anniek W. Gotink, MD 3, Kenneth K. Wang, MD, PhD 11, Cadman L. Leggett, MD, PhD 11, Jacobo Ortiz-Fernández-Sordo, MD, PhD 12, Krish Ragunath, MD, PhD 12, Massimiliano DiPietro, MD, PhD 13, Oliver Pech, MD, PhD 14, Horst Neuhaus, MD, PhD 2, Jacques J. Bergman, MD, PhD 1
1 Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands 
2 Department of Gastroenterology and Hepatology, Evangelisches Krankenhaus, Düsseldorf, Germany 
3 Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, Netherlands 
4 Department of Gastroenterology and Hepatology, Catharina Hospital Eindhoven, Eindhoven, Netherlands 
5 Department of Gastroenterology, University College Hospital, London, United Kingdom 
6 Department of Gastroenterology, St Antonius Hospital, Nieuwegein, Netherlands 
7 Department of Gastroenterology, UZ Gasthuisberg, Leuven, Belgium 
8 Department of Gastroenterology, University North Carolina Hospital, Chapel Hill, North Carolina, USA 
9 Department of Gastroenterology, Mayo Clinic Florida, Jacksonville, Florida, USA 
10 Department of Gastroenterology, St Michaels Hospital, Toronto, Ontario, Canada 
11 Department of Gastroenterology, Mayo Clinic Rochester, Rochester, Minnesota, USA 
12 Nottingham Digestive Diseases Centre, University of Nottingham and NIHR Nottingham BRC, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom 
13 Department of Gastroenterology, University of Cambridge, Cambridge, United Kingdom 
14 Department of Gastroenterology, St John of God Hospital, Regensburg, Germany 

Reprint requests: R. E. Pouw, MD, PhD, Department of Gastroenterology and Hepatology, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, Netherlands.Department of Gastroenterology and HepatologyAcademic Medical CenterMeibergdreef 9, 1105 AZAmsterdamNetherlands

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.)

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Abbreviations : BE, CI, ER, HGD, IQR, MBM


Plan


 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.
 If you would like to chat with an author of this article, you may contact Dr Pouw at r.e.pouw@amc.uva.nl.


© 2018  American Society for Gastrointestinal Endoscopy. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 88 - N° 4

P. 647-654 - octobre 2018 Retour au numéro
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