多功能套扎器在结直肠内镜黏膜下剥离术中的应用评价：一项前瞻性临床可行性研究（附视频）。
Evaluation of colorectal endoscopic submucosal dissection using a multifunctional snare: a prospective clinical feasibility study (with videos).
机构信息
Department of Gastroenterology, Omori Red Cross Hospital, Tokyo, Japan.
Department of Gastroenterology, NTT Medical Center Tokyo, Tokyo, Japan.
出版信息
Gastrointest Endosc. 2021 Mar;93(3):671-678. doi: 10.1016/j.gie.2020.09.019. Epub 2020 Sep 18.
BACKGROUND AND AIMS
The number of colorectal endoscopic submucosal dissections (ESDs) for early colorectal cancer is expected to increase in the future; therefore, cost reduction is a clinically important issue. The SOUTEN snare (Kaneka Medics, Tokyo, Japan) is a novel multifunctional snare developed for hybrid ESD at a low price. If ESD can be performed safely using the SOUTEN snare, the same therapeutic effect can be obtained as with conventional ESD at a lower cost. The aim of this prospective, pilot, clinical feasibility study was to evaluate the safety and efficacy of ESD using the SOUTEN snare (SOUTEN-ESD).
METHODS
From October 2018 to January 2019, 119 consecutive patients (121 ESD procedures, 137 colorectal neoplasms) were prospectively enrolled and treated by SOUTEN-ESD at NTT Medical Center Tokyo and Omori Red Cross Hospital. The outcomes of SOUTEN-ESD were evaluated.
RESULTS
Among 137 neoplasms, SOUTEN-ESD was completed in all cases. No cases required conversion to hybrid ESD or to a dedicated ESD device. The mean procedure time was 26.1 ± 14.3 minutes. Both the en-bloc resection rate and R0 resection rate were 100%. The rate of perforation was 0%, the rate of delayed bleeding was 2.2%, and the rate of post-ESD coagulation syndrome was 2.9%.
CONCLUSIONS
SOUTEN-ESD was safe and had good outcomes. Although further studies are required to examine indications for SOUTEN-ESD and confirm the results of this study, effective ESD with this novel knife is feasible. The SOUTEN snare is a realistic option for colorectal ESD. (Clinical trial registration number: UMIN 000034299.).
背景与目的
预计未来早期结直肠癌的结直肠内镜黏膜下剥离术（ESD）数量将会增加；因此，降低成本是一个具有临床重要意义的问题。Souten 套扎器（日本 Kaneka Medics）是一种新型的多功能套扎器，专为混合 ESD 开发，价格低廉。如果使用 Souten 套扎器可以安全地进行 ESD，则可以以更低的成本获得与传统 ESD 相同的治疗效果。本前瞻性、初步、临床可行性研究的目的是评估使用 Souten 套扎器（Souten-ESD）进行 ESD 的安全性和有效性。
方法
2018 年 10 月至 2019 年 1 月，连续前瞻性纳入 119 例患者（121 例 ESD 手术，137 例结直肠肿瘤），在 NTT 医疗中心东京和大森红十字医院接受 Souten-ESD 治疗。评估 Souten-ESD 的结果。
结果
在 137 个肿瘤中，所有病例均完成了 Souten-ESD。无一例需要转换为混合 ESD 或专用 ESD 设备。平均手术时间为 26.1±14.3 分钟。整块切除率和 R0 切除率均为 100%。穿孔率为 0%，延迟出血率为 2.2%，术后凝血综合征发生率为 2.9%。
结论
Souten-ESD 是安全且有良好结果的。尽管需要进一步研究来检查 Souten-ESD 的适应证并确认本研究的结果，但使用这种新型刀进行有效的 ESD 是可行的。Souten 套扎器是结直肠 ESD 的一种现实选择。（临床试验注册号：UMIN 000034299.）。
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