Efficacy of an internal traction device in colorectal endoscopic submucosal dissection: a multicenter randomized controlled trial.

BACKGROUND AND AIM: Shortening the procedure time and reducing the incidence of complications are important in patients undergoing colorectal endoscopic submucosal dissection (ESD). This prospective randomized controlled trial assessed the efficacy and safety of colorectal ESD with an internal traction-assisted device (IT-ESD) by comparing its outcomes with those of conventional ESD (without internal traction-assisted device) in patients with colorectal epithelial neoplasia.

METHODS

A total of 201 patients who underwent ESD between March 2020 and April 2023 were prospectively randomized to IT-ESD or conventional ESD. The primary endpoint was procedure time. Secondary endpoints included rates of procedural complications, en bloc resection, curative resection, conversion, and adverse events.

RESULTS

Mean procedure time was significantly shorter in patients who underwent IT-ESD than conventional ESD (95.8 ± 59.5 vs. 114.7 ± 68.3 min; p = 0.041). Although ESD trainees tended to take less time to perform IT-ESD than conventional ESD (103.2 ± 63.2 min vs 128.7 ± 76.2 min, p = 0.075), no statistically significant difference was observed. Overall complication rates associated with the procedure did not differ significantly who underwent IT-ESD and conventional ESD (13.0% vs. 17.8%; p = 0.435). Intraoperative perforations tended to be more common in conventional (7.1%) than IT-ESD (2.0%). When stratified by lesion location, procedure time was significantly shorter for IT-ESD than for conventional ESD at colon than rectum (92.9 ± 55.2 vs. 117.3 ± 69.3 min; p = 0.013).

CONCLUSIONS

IT-ESD significantly reduces procedure time and may enhance procedural efficiency. Furthermore, IT-ESD may contribute to improved safety and is considered particularly advantageous for colonic lesions.

TRIAL REGISTRATION: The Japan Registry of Clinical Trials (JRCT; trial registration: jRCT052190089). Registered on December 25, 2019. https://jrct.niph.go.jp/latest-detail/jRCTs052190089 jRCT052190089 Version number: 4.0.

TRIAL STATUS: Protocol version number: 2.4.