Efficacy and Safety of ClearCut™ Knife H-type in Endoscopic Submucosal Dissection for Gastric Neoplasms: A Multicenter, Randomized Trial

PURPOSE: Endoscopic submucosal dissection (ESD) is an effective treatment for early gastrointestinal neoplasms. However, this is a time-consuming procedure requiring various devices. This study aimed to evaluate the efficacy and safety of the ClearCut™ Knife H-type, which is an integrated needle-tipped and insulated-tipped (IT) knife. MATERIALS AND METHODS: Between July 2020 and September 2021, 99 patients with gastric epithelial neoplasms scheduled for ESD at three tertiary care hospitals were randomly assigned to H-knife (ClearCut™ Knife H-type) or IT-knife (conventional IT knife) groups. Procedure times, therapeutic outcomes, and adverse events were analyzed. RESULTS: A total of 98 patients (50 in the H-knife group and 48 in the IT-knife group) were analyzed. The median total procedure time was 11.9 minutes (range, 4.4–47.2 minutes) in the H-knife group and 12.7 minutes (range, 5.2–137.7 minutes) in the IT-knife group (P=0.209). Unlike the IT-knife group, which required additional devices in all cases, no additional devices were used in the H-knife group (P<0.001). En-bloc resection was performed for all lesions in both groups. The incidence of adverse events was not significantly different between groups (4.0% in the H-knife group vs. 8.3% in the IT-knife group; P=0.431). CONCLUSIONS: The newly developed hybrid device, the ClearCut™ Knife H-type, had comparable efficacy to the conventional IT knife for gastric ESD. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0005164