Efficacy and safety of multi-loop traction device-assisted colorectal endoscopic submucosal dissection: Multicenter randomized clinical trial

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 mm²/min; interquartile range [IQR] 8.9–23.9 mm²/min vs. 13.3 mm²/min; IQR 8.9–18.8 mm²/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 mm²/min; IQR 15.5–28.8 mm²/min vs. 14.4 mm²/min; IQR 9.9–21.2 mm²/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.

Keywords

Endoscopy Lower GI Tract - Polyps / adenomas / ... - Colorectal cancer - Endoscopic resection (polypectomy, ESD, EMRc, ...)

• References

• 1 Ono H, Kondo H, Gotoda T. et al. Endoscopic mucosal resection for treatment of early gastric cancer. Gut 2001; 48: 225-229
• 2 Saito Y, Fukuzawa M, Matsuda T. et al. Clinical outcome of endoscopic submucosal dissection versus endoscopic mucosal resection of large colorectal tumors as determined by curative resection. Surg Endosc 2010; 24: 343-352
• 3 Isomoto H, Shikuwa S, Yamaguchi N. et al. Endoscopic submucosal dissection for early gastric cancer: a large-scale feasibility study. Gut 2009; 58: 331-336
• 4 Lee BI. Debates on colorectal endoscopic submucosal dissection – traction for effective dissection: gravity is enough. Clin Endosc 2013; 46: 467-471
• 5 Noda M, Kobayashi N, Kanemasa H. et al. Endoscopic mucosal resection using a partial transparent hood for lesions located tangentially to the endoscope. Gastrointest Endosc 2000; 51: 338-343
• 6 Ritsuno H, Sakamoto N, Osada T. et al. Prospective clinical trial of traction device-assisted endoscopic submucosal dissection of large superficial colorectal tumors using the S-O clip. Surg Endosc 2014; 28: 3143-3149
• 7 Yamada S, Doyama H, Ota R. et al. Impact of the clip and snare method using the prelooping technique for colorectal endoscopic submucosal dissection. Endoscopy 2016; 48: 281-285
• 8 Mori H, Kobara H, Nishiyama N. et al. Novel effective and repeatedly available ring-thread counter traction for safer colorectal endoscopic submucosal dissection. Surg Endosc 2017; 31: 3040-3047
• 9 Ye L, Yuan X, Pang M. et al. Magnetic bead-assisted endoscopic submucosal dissection: a gravity-based traction method for treating large superficial colorectal tumors. Surg Endosc 2019; 33: 2034-2041
• 10 Sakamoto H, Hayashi Y, Miura Y. et al. Pocket-creation method facilitates endoscopic submucosal dissection of colorectal laterally spreading tumors, non-granular type. Endosc Int Open 2017; 5: E123-E129
• 11 Yamasaki Y, Takeuchi Y, Uedo N. et al. Efficacy of traction-assisted colorectal endoscopic submucosal dissection using a clip-and-thread technique: a prospective randomized study. Dig Endosc 2018; 30: 467-476
• 12 Tziatzios G, Ebigbo A, Golder SK. et al. Methods that assist traction during endoscopic submucosal dissection of superficial gastrointestinal cancers: a systematic literature review. Clin Endosc 2020; 53: 286-301
• 13 Yoshida M, Takizawa K, Nonaka S. et al. Conventional versus traction-assisted endoscopic submucosal dissection for large esophageal cancers: a multicenter, randomized controlled trial (with video). Gastrointest Endosc 2020; 91: 55-65
• 14 Yoshida M, Takizawa K, Suzuki S. et al. Conventional versus traction-assisted endoscopic submucosal dissection for gastric neoplasms: a multicenter, randomized controlled trial (with video). Gastrointest Endosc 2018; 87: 1231-1240
• 15 Coman RM, Gotoda T, Draganov PV. Training in endoscopic submucosal dissection. World J Gastrointest Endosc 2013; 5: 369-378
• 16 Ohata K, Ito T, Chiba H. et al. Effective training system in colorectal endoscopic submucosal dissection. Dig Endosc 2012; 24: 84-89
• 17 Sakamoto T, Saito Y, Fukunaga S. et al. Learning curve associated with colorectal endoscopic submucosal dissection for endoscopists experienced in gastric endoscopic submucosal dissection. Dis Colon Rectum 2011; 54: 1307-1312
• 18 Ichijima R, Ikehara H, Sumida Y. et al. Randomized controlled trial comparing conventional and traction endoscopic submucosal dissection for early colon tumor (CONNECT-C trial). Dig Endosc 2023; 35: 86-93
• 19 Matsui H, Tamai N, Futakuchi T. et al. Multi-loop traction device facilitates gastric endoscopic submucosal dissection: ex vivo pilot study and an inaugural clinical experience. BMC Gastroenterol 2022; 22: 10
• 20 Jinushi R, Tashima T, Terada R. et al. Effectiveness of a multi-loop traction device for colorectal endoscopic submucosal dissection performed by trainees: a pilot study. Sci Rep 2022; 12: 10197
• 21 Bordillon P, Pioche M, Wallenhorst T. et al. Double-clip traction for colonic endoscopic submucosal dissection: a multicenter study of 599 consecutive cases (with video). Gastrointest Endosc 2021; 94: 333-43