Roos E Pouw1, Torsten Beyna2, Kamar Belghazi1, Arjun D Koch3, Erik J Schoon4, Rehan Haidry5, Bas L Weusten6, Raf Bisschops7, Nicholas J Shaheen8, Michael B Wallace9, Norman Marcon10, Rachel Heise-Ginsburg2, Anniek W Gotink3, Kenneth K Wang11, Cadman L Leggett11, Jacobo Ortiz-Fernández-Sordo12, Krish Ragunath12, Massimiliano DiPietro13, Oliver Pech14, Horst Neuhaus2, Jacques J Bergman1. 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.
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.).
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.).