Chiu Philip W Y, Yip Hon Chi, Chu Simon, Chan Shannon M, Lau Ho Shing Louis, Tang Raymond S Y, Phee Soo Jay, Ho Khek Yu, Ng Simon Siu Man
Surgery, The Chinese University of Hong Kong, Hong Kong, Hong Kong.
Institute of Digestive Disease and State Key Laboratory of GI Diseases, The Chinese University of Hong Kong, Hong Kong, Hong Kong.
Endoscopy. 2025 Mar;57(3):240-246. doi: 10.1055/a-2411-0892. Epub 2024 Sep 6.
The development of the EndoMaster "Endoluminal Access Surgical Efficacy" (EASE) system aims to enhance the safety and efficacy of colonic endoscopic submucosal dissection (ESD) through two flexible robotic arms. This is the first clinical trial to evaluate the performance of colorectal ESD using EndoMaster.
Patients with early mucosal colorectal neoplasia that was not suitable for en bloc resection with snare-based techniques were recruited. The EndoMaster EASE robotic system consisted of an independently designed flexible robotic platform with two robotic arms. The primary outcome was the complete resection rate using EndoMaster. Secondary outcomes included operating time, hospital stay, procedure-related complications, and oncologic outcomes.
43 patients underwent robotic ESD, with a median robotic dissection time of 49 minutes. The technical success rate was 86.0%, while en bloc resection rate among cases with technical success was 94.6%. The complete resection rate was 83.8% and the median size of specimen was 35 mm (range 15-90 mm). The median hospital stay was 2 (range 1-7) days and there was one delayed bleed after 4 days, which was controlled endoscopically. One patient sustained perforation during the procedure, which was completely closed using clips without sequelae. Two patients were treated by salvage surgery.
This first clinical trial confirmed the safety and efficacy of performing colorectal ESD using the EndoMaster EASE robotic system.
EndoMaster“腔内入路手术疗效”（EASE）系统的研发旨在通过两个灵活的机械臂提高结肠内镜黏膜下剥离术（ESD）的安全性和有效性。这是第一项评估使用EndoMaster进行结直肠ESD性能的临床试验。
招募了不适合采用基于圈套器技术整块切除的早期结直肠黏膜肿瘤患者。EndoMaster EASE机器人系统由一个独立设计的带有两个机械臂的灵活机器人平台组成。主要结局是使用EndoMaster的完整切除率。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。
43例患者接受了机器人ESD，机器人剥离的中位时间为49分钟。技术成功率为86.0%，技术成功的病例中整块切除率为94.6%。完整切除率为83.8%，标本的中位大小为35 mm（范围15 - 90 mm）。中位住院时间为2（范围1 - 7）天，4天后出现1例延迟出血，经内镜控制。1例患者在手术过程中发生穿孔，使用夹子完全封闭，无后遗症。2例患者接受了挽救性手术。
第一项临床试验证实了使用EndoMaster EASE机器人系统进行结直肠ESD的安全性和有效性。
