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

Roos E. Pouw, Torsten Beyna, Kamar Belghazi, Arjun D. Koch, Erik J. Schoon, Rehan Haidry, Bas L. Weusten, Raf Bisschops, Nicholas J. Shaheen, Michael B Wallace, Norman Marcon, Rachel Heise-Ginsburg, Anniek W. Gotink, Kenneth Ke Ning Wang, Cadman Leggett, Jacobo Ortiz-Fernández-Sordo, Krish Ragunath, Massimiliano DiPietro, Oliver Pech, Horst NeuhausJacques J. Bergman

Research output: Contribution to journalArticle

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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.)

Original languageEnglish (US)
JournalGastrointestinal Endoscopy
DOIs
StateAccepted/In press - Jan 1 2018

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Barrett Esophagus
Multicenter Studies
Prospective Studies
Equipment and Supplies
Confidence Intervals
Neoplasms
Suction
Deglutition Disorders
Canada
Registries
Dilatation
Histology
Adenocarcinoma
Referral and Consultation
Hand
Clinical Trials
Hemorrhage
Anti-Bacterial Agents

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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A prospective multicenter study using a new multiband mucosectomy device for endoscopic resection of early neoplasia in Barrett's esophagus. / 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 Ke Ning; Leggett, Cadman; Ortiz-Fernández-Sordo, Jacobo; Ragunath, Krish; DiPietro, Massimiliano; Pech, Oliver; Neuhaus, Horst; Bergman, Jacques J.

In: Gastrointestinal Endoscopy, 01.01.2018.

Research output: Contribution to journalArticle

Pouw, RE, Beyna, T, Belghazi, K, Koch, AD, Schoon, EJ, Haidry, R, Weusten, BL, Bisschops, R, Shaheen, NJ, Wallace, MB, Marcon, N, Heise-Ginsburg, R, Gotink, AW, Wang, KKN, Leggett, C, Ortiz-Fernández-Sordo, J, Ragunath, K, DiPietro, M, Pech, O, Neuhaus, H & Bergman, JJ 2018, 'A prospective multicenter study using a new multiband mucosectomy device for endoscopic resection of early neoplasia in Barrett's esophagus', Gastrointestinal Endoscopy. https://doi.org/10.1016/j.gie.2018.06.030
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 Ke Ning ; Leggett, Cadman ; Ortiz-Fernández-Sordo, Jacobo ; Ragunath, Krish ; DiPietro, Massimiliano ; Pech, Oliver ; Neuhaus, Horst ; Bergman, Jacques J. / A prospective multicenter study using a new multiband mucosectomy device for endoscopic resection of early neoplasia in Barrett's esophagus. In: Gastrointestinal Endoscopy. 2018.
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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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T1 - A prospective multicenter study using a new multiband mucosectomy device for endoscopic resection of early neoplasia in Barrett's esophagus

AU - Pouw, Roos E.

AU - Beyna, Torsten

AU - Belghazi, Kamar

AU - Koch, Arjun D.

AU - Schoon, Erik J.

AU - Haidry, Rehan

AU - Weusten, Bas L.

AU - Bisschops, Raf

AU - Shaheen, Nicholas J.

AU - Wallace, Michael B

AU - Marcon, Norman

AU - Heise-Ginsburg, Rachel

AU - Gotink, Anniek W.

AU - Wang, Kenneth Ke Ning

AU - Leggett, Cadman

AU - Ortiz-Fernández-Sordo, Jacobo

AU - Ragunath, Krish

AU - DiPietro, Massimiliano

AU - Pech, Oliver

AU - Neuhaus, Horst

AU - Bergman, Jacques J.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.)

AB - 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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