简介 EndoMaster EASE 系统的开发旨在通过两个灵活的机械臂进行组织牵开和解剖，从而提高结肠 ESD 的安全性和有效性。这是第一个使用 EndoMaster 评估结直肠 ESD 性能的临床试验。方法 招募了无法采用圈套器技术进行整块切除的早期粘膜结直肠肿瘤患者。 EndoMaster EASE 机器人系统由独立设计的柔性机器人平台和 2 个机械臂组成。主要结果是使用 EndoMaster 的完全切除率。次要结局包括手术时间、住院时间、手术相关并发症和肿瘤学结局。结果 2020年5月至2022年1月，43名患者接受了机器人ESD，中位年龄为66岁（40-83岁）。平均机器人解剖时间为 62.0 ± 45.1 分钟。除 6 例外，所有手术均使用 EndoMaster 完成，技术成功率为 86.1% (37/43)。技术成功的病例整块切除率为94.6%（35/37），完全切除率为83.8%（31/37）。样本的中值尺寸为35mm（15-90mm）。平均住院时间为 2.6 ± 1.2 天，ESD 后 4 天出现 1 次迟发性出血，经内窥镜检查控制。一名患者在手术过程中发生穿孔，使用夹子完全闭合，没有留下后遗症。 2 例患者因组织病理学显示腺癌累及边缘深部而需进行挽救手术。结论 第一项临床试验证实了使用 EndoMaster EASE 机器人系统（Clinicaltrial.gov：NCT04196062）进行结直肠 ESD 的安全性和有效性。Thieme。版权所有。

Introduction The development of EndoMaster EASE system aims to enhance safety and efficacy of colonic ESD through two flexible robotic arms for tissue retraction and dissection. This is the first clinical trial to evaluate the performance of colorectal ESD using EndoMaster. Method Patients with early mucosal colorectal neoplasia not feasible for en-bloc resection with snare-based techniques were recruited. The EndoMaster EASE robotic system consisted of an independently designed flexible robotic platform with 2 robotic arms. The primary outcome was complete resection rate using EndoMaster. Secondary outcomes included operating time, hospital stay, procedure-related complications and oncological outcomes. Results From May 2020 to Jan 2022, 43 patients received robotic ESD with median age of 66 years (40-83). The mean robotic dissection time was 62.0 ± 45.1 minutes. All procedures except six were completed using EndoMaster with technical success rate of 86.1% (37/43). The en-bloc resection rate among cases with technical success was 94.6% (35/37) while the complete resection rate was 83.8% (31/37). The median size of specimen was 35mm (15-90mm). The mean hospital stay was 2.6 ± 1.2 days and there was one delayed bleeding 4 days after ESD which was controlled by endoscopy. One patient sustained perforation during procedure which was completely closed using clips without sequelae. 2 patients required salvage surgery due to deep margin involvement by adenocarcinoma in histopathology. Conclusion This first clinical trial confirmed the safety and efficacy of performing colorectal ESD using EndoMaster EASE robotic system (Clinicaltrial.gov: NCT04196062).Thieme. All rights reserved.