Safety and efficacy of traction robot-assisted endoscopic submucosal dissection for early gastric cancer: a randomized pilot trial

Abstract

Background

Several animal studies have demonstrated the safety and efficacy of a flexible auxiliary single-arm transluminal endoscopic robot in assisting gastric endoscopic submucosal dissection (ESD). This study aimed to assess its performance for the first time in a real clinical setting.

Methods

We conducted this prospective, single-blind, pilot randomized controlled trial at a tertiary teaching hospital. Patients with gastric high grade intraepithelial neoplasia or intramucosal carcinoma were randomized to either robot-assisted or conventional ESD. The primary outcome was procedure time. Secondary outcomes included R0 and en bloc resection rates, dissection time, and procedure-related complications.

Results

48 patients underwent successful procedures without perforation. Despite no significant difference in procedure time between robot-assisted and conventional ESD (58.21 vs. 39.21 minutes; P = 0.08), a learning curve effect was observed, with shorter procedure times in the last 12 cases with robot assistance compared with the last 12 conventional ESDs (56.82 vs. 63.10 minutes; P = 0.71). Muscular injuries were significantly reduced with robot assistance (1.50 vs. 9.00; P < 0.001). No significant difference was found in R0 (95.8% vs. 91.7%; P > 0.99) and en bloc (100% vs. 95.8%; P > 0.99) resection rates between robot-assisted and conventional ESD, respectively.

Conclusions

This preliminary evidence supports the feasibility of robot-assisted gastric ESD.

Publication History

Received: 24 April 2025

Accepted after revision: 03 August 2025

Article published online:
02 December 2025

• References

• 1 Bourke MJ, Neuhaus H, Bergman JJ. Endoscopic submucosal dissection: indications and application in Western endoscopy practice. Gastroenterology 2018; 154: 1887-1900
• 2 Su YF, Cheng SW, Chang CC. et al. Efficacy and safety of traction-assisted endoscopic submucosal dissection: a meta-regression of randomized clinical trials. Endoscopy 2020; 52: 338-348
• 3 Morikawa T, Nemoto D, Kurokawa T. et al. Multicenter prospective randomized controlled clinical trial comparing the pocket-creation method with and without single-clip traction of colonic endoscopic submucosal dissection. Endoscopy 2024; 56: 583-593
• 4 Nishioka K, Esaki M, Iwasa T. et al. Two-step traction-assisted endoscopic submucosal dissection for a gastric neoplasm using a clip with a traction band and thread. Endoscopy 2023; 55: E1041-E1042
• 5 Yoshida N, Doyama H, Ota R. et al. Effectiveness of clip-and-snare method using pre-looping technique for gastric endoscopic submucosal dissection. World J Gastrointest Endosc 2016; 8: 451
• 6 Nagata M, Fujikawa T, Munakata H. Comparing a conventional and a spring-and-loop with clip traction method of endoscopic submucosal dissection for superficial gastric neoplasms: a randomized controlled trial (with videos). Gastrointest Endosc 2021; 93: 1097-1109
• 7 Gao Y, Liu W, Ye L. et al. Magnet-assisted traction method helps to reduce the difficulty of esophageal endoscopic submucosal dissection. Endoscopy 2023; 55: E1186-E1188
• 8 Ji R, Yang JL, Yang XX. et al. Simplified robot-assisted endoscopic submucosal dissection for esophageal and gastric lesions: a randomized controlled porcine study (with videos). Gastrointest Endosc 2022; 96: 140-147
• 9 Yang XX, Fu SC, Ji R. et al. A novel flexible auxiliary single-arm transluminal endoscopic robot facilitates endoscopic submucosal dissection of gastric lesions (with video). Surg Endosc 2022; 36: 5510-5517
• 10 Yang XX, Fu SC, Li LX. et al. Robot-assisted endoscopic submucosal dissection contributes to efficient and safe learning for novices: prospective pilot cross-over ex vivo study (with video). Dig Endosc 2023; 35: 342-351
• 11 Eldridge SM, Chan CL, Campbell MJ. et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016; 355: i5239
• 12 Libânio D, Pimentel-Nunes P, Bastiaansen B. et al. Endoscopic submucosal dissection techniques and technology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy 2023; 55: 361-389
• 13 Jeon SW, Jung MK, Cho CM. et al. Predictors of immediate bleeding during endoscopic submucosal dissection in gastric lesions. Surg Endosc 2009; 23: 1974-1979
• 14 Wang F, Leng X, Gao Y. et al. Endoscopic submucosal dissection of distal intestinal tumors using grasping forceps for traction. Tech Coloproctol 2019; 23: 1079-1083
• 15 Zheng S, Ali FS, Zhang J. et al. Endoscopic traction techniques. Am J Gastroenterol 2021; 116: 862-866
• 16 Cui C, Lu XF, Zuo XL. et al. Endoscopic submucosal dissection of early gastric angle cancer by using a simplified robot-assisted device for traction. Endoscopy 2024; 56: E49-E50
• 17 Teoh AY, Chiu PW, Hon SF. et al. Ex vivo comparative study using the Endolifter as a traction device for enhancing submucosal visualization during endoscopic submucosal dissection. Surg Endosc 2013; 27: 1422-1427
• 18 Ritsuno H, Sakamoto N, Osada T. et al. Prospective clinical trial of traction device-assisted endoscopic submucosal dissection of large superficial colorectal tumors using the S-O clip. Surg Endosc 2014; 28: 3143-3149
• 19 Kim SH, Kim C, Keum B. et al. A novel retractable robotic device for colorectal endoscopic submucosal dissection. Gut Liver 2024; 18: 677-685
• 20 Turiani Hourneaux de Moura D, Aihara H, Jirapinyo P. et al. Robot-assisted endoscopic submucosal dissection versus conventional ESD for colorectal lesions: outcomes of a randomized pilot study in endoscopists without prior ESD experience (with video). Gastrointest Endosc 2019; 90: 290-298