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

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A prospective multicenter study using a new multiband mucosectomy device for endoscopic resection of early neoplasia in Barrett’s esophagus
Gastrointestinal Endoscopy ( IF 7.7 ) Pub Date : 2018-07-06 , DOI: 10.1016/j.gie.2018.06.030
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 K. Wang , Cadman L. Leggett , Jacobo Ortiz-Fernández-Sordo , Krish Ragunath , Massimiliano DiPietro , Oliver Pech , Horst Neuhaus , Jacques J. Bergman

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.)

中文翻译：

使用新型多波段粘膜切除装置对巴雷特食管的早期赘生物进行内窥镜切除的前瞻性多中心研究

背景和目标

可以使用多波段粘膜切除术（MBM）在内窥镜切除术（ER）来有效，安全地去除Barrett食道（BE）中的早期肿瘤。这项研究旨在证明新型MBM设备的性能，该MBM设备与其他市售的MBM设备相比，旨在提高可视化性，使配件更容易通过，并具有更好的吸力。

方法

在14个转诊中心（欧洲，10个，美国，3个，加拿大，1个）中，这个国际性的单臂，前瞻性注册中心包括了计划进行ER的早期BE瘤形成的患者。主要终点为成功的ER，定义为1例手术完全切除了划定的区域。次要结果是不良事件和手术时间。

结果

291位患者（248名男性，平均年龄67岁，标准差9.6）中包括了332个病变。ER指征是高度不典型增生为64％，早期腺癌为19％，低度不典型增生的病变为11％，无明确组织学的病变为6％。332个病变中的322个达到了成功的ER（97％； 95％置信区间[CI]，94.6％-98.4％）。332例手术中有3例发生穿孔（0.9％； 95％CI，.31％-2.62％），所有手术均通过内窥镜处理，患者在第2、3和9天接受了静脉抗生素治疗。 332例切除中有5例进行了干预（1.5％； 95％CI，.65％-3.48％）。需要扩张的吞咽困难发生在11例患者中（3.8％; 95％CI，2.1％-6.6％）。中位手术时间为16分钟（四分位间距12.0-26.0）。