Efficacy and Safety of a Novel All In One Device for Colorectal Hybrid ESD: A Multicenter Prospective Study

INTRODUCTION: This study aimed to verify the efficacy and safety of a novel all-in-one device for colorectal hybrid endoscopic submucosal dissection (ESD). We further evaluated its clinical outcomes and cost- effectiveness compared with conventional ESD. METHODS: All In One (AIO) assisted hybrid ESD was prospectively performed on 161 patients (173 colorectal neoplasms) across five centers from November 2021 to November 2022.The primary outcome was the en bloc resection rate. Secondary outcomes were the complete resection rate and the incidences of adverse events. For the secondary retrospective comparative analysis, 345 patients (362 colorectal neoplasms) who underwent conventional ESD in the lead center during the same period were retrospectively identified and include to compare with the AIO group for outcomes and cost-effectiveness. RESULTS: In the prospective study, the en bloc resection rate was 97.7% (169/173), and the complete resection rate was 94.2% (163/173). The intraoperative and postoperative bleeding rates were 4.6% (8/173) and 1.2% (2/173). No perforation or abdominal pain was observed, and the incidence of fever was 1.2% (2/173). In the propensity score-matched retrospective comparison, the en bloc resection rates were 97.8% in AIO groups and 96.3% in conventional group (p=0.722). The complete resection rates were 94.8% in both groups. There was no difference between the adverse events rates (all p>0.05). It also demonstrated significantly reduced procedural time and costs with AIO assisted hybrid ESD (both p<0.001). CONCLUSIONS: The novel AIO device for colorectal hybrid ESD is safe and effective. It also reduced the procedural time and cost compared to convention ESD.