Mitsuru Nagata1, Tomoaki Fujikawa2, Hiromi Munakata2. 1. Department of Endoscopy, Shonan Fujisawa Tokushukai Hospital, Fujisawa-shi, Kanagawa, Japan. 2. Center for Digestive and Hepato-Biliary-Pancreatic disease, Shonan Fujisawa Tokushukai Hospital, Fujisawa-shi, Kanagawa, Japan.
Abstract
BACKGROUND AND AIMS: Several traction methods have sought to overcome the technical difficulties of endoscopic submucosal dissection (ESD). However, traction direction has remained limited in most of these methods, with lack of clarity about the optimal method and traction direction for gastric ESD. A spring-and-loop with clip (SLC) has been developed as a multidirectional traction device. Here, we investigated whether SLC traction-assisted ESD (SLC-ESD) improved procedure-related outcomes compared with conventional ESD (C-ESD) among patients with superficial gastric neoplasms. METHODS: This single-center randomized controlled trial included patients with superficial gastric neoplasms undergoing SLC-ESD or C-ESD between October 2018 and December 2019. Using the multidirectional traction function, we set traction vertical to the gastric wall for SLC-ESD. The primary outcome was the median procedure time for gastric ESD. RESULTS: The SLC-ESD and C-ESD groups comprised 40 patients each, and all the enrolled patients underwent the assigned treatment. The median ESD procedure time was significantly shorter in the SLC-ESD group (29.1 minutes) than in the C-ESD group (52.6 minutes; P = .005). SLC had a mean attachment time of 1.82 minutes. En bloc resection was achieved without perforation in all the patients in both groups. CONCLUSIONS: Our findings suggest that SLC-ESD reduces gastric ESD procedure time without increasing the risk of perforation and that the vertical direction to the gastric wall is the appropriate traction direction for gastric ESD. (Clinical trial registration number: UMIN 000034533.).
RCT Entities:
BACKGROUND AND AIMS: Several traction methods have sought to overcome the technical difficulties of endoscopic submucosal dissection (ESD). However, traction direction has remained limited in most of these methods, with lack of clarity about the optimal method and traction direction for gastric ESD. A spring-and-loop with clip (SLC) has been developed as a multidirectional traction device. Here, we investigated whether SLC traction-assisted ESD (SLC-ESD) improved procedure-related outcomes compared with conventional ESD (C-ESD) among patients with superficial gastric neoplasms. METHODS: This single-center randomized controlled trial included patients with superficial gastric neoplasms undergoing SLC-ESD or C-ESD between October 2018 and December 2019. Using the multidirectional traction function, we set traction vertical to the gastric wall for SLC-ESD. The primary outcome was the median procedure time for gastric ESD. RESULTS: The SLC-ESD and C-ESD groups comprised 40 patients each, and all the enrolled patients underwent the assigned treatment. The median ESD procedure time was significantly shorter in the SLC-ESD group (29.1 minutes) than in the C-ESD group (52.6 minutes; P = .005). SLC had a mean attachment time of 1.82 minutes. En bloc resection was achieved without perforation in all the patients in both groups. CONCLUSIONS: Our findings suggest that SLC-ESD reduces gastric ESD procedure time without increasing the risk of perforation and that the vertical direction to the gastric wall is the appropriate traction direction for gastric ESD. (Clinical trial registration number: UMIN 000034533.).