Abstract
BACKGROUND AND STUDY AIMS: The multi-loop traction device (MLTD) facilitates optimal visualization of the submucosa throughout endoscopic submucosal dissection (ESD). This trial aimed to assess the efficacy of MLTD for colorectal ESD. PATIENTS AND METHODS: We conducted a multicenter, open-label, randomized controlled trial involving patients with colorectal lesions ≥ 20 mm suspicious for noninvasive carcinoma. Participants were randomly assigned in a 1:1 ratio to undergo ESD with MLTD (MLTD-ESD group) or ESD without any traction device (control group). Endoscopists were allowed to convert treatments if dissection became challenging for 10 minutes. The primary endpoint was dissection speed; secondary endpoints included technical success rate and adverse events (AEs). RESULTS: A total of 108 participants were randomized to the MLTD-ESD group (n = 53) and the control group (n = 55). There was no statistically significant difference in median dissection speed between the MLTD-ESD group and the control group (14.8 mm (2) /min; interquartile range [IQR] 8.9-23.9 mm (2) /min vs. 13.3 mm (2) /min; IQR 8.9-18.8 mm (2) /min) ( P = 0.33). The technical success rate was significantly higher in the MLTD-ESD group (96.2%) compared with the control group (71.0%) ( P < 0.0001). All technical failures were due to treatment conversions. No significant difference was observed in AEs. Subgroup analysis revealed that experts in the MLTD-ESD group had faster dissection speed than controls (21.6 mm(2)/min; IQR 15.5-28.8 mm (2) /min vs. 14.4 mm (2) /min; IQR 9.9-21.2 mm (2) /min) ( P = 0.009). CONCLUSIONS: This multicenter randomized trial demonstrated that use of MLTD did not significantly increase dissection speed for colorectal ESD. Treatment conversions may have influenced the primary endpoint, and further investigation is warranted.