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CC BY 4.0 · Endosc Int Open 2025; 13: a24660718
DOI: 10.1055/a-2466-0718
Original article

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

Mamoru Ito
1   Department of Endoscopy, The Jikei University School of Medicine, Minato-ku, Japan (Ringgold ID: RIN12839)
,
Yuko Miura
2   Department of Gastroenterology, The University of Tokyo, Bunkyo-ku, Japan (Ringgold ID: RIN13143)
,
Yasuhiko Mizuguchi
3   Endoscopy Division, National Cancer Center Hospital, Chuo-ku, Japan (Ringgold ID: RIN68380)
,
Hiroto Furuhashi
1   Department of Endoscopy, The Jikei University School of Medicine, Minato-ku, Japan (Ringgold ID: RIN12839)
,
Yosuke Tsuji
2   Department of Gastroenterology, The University of Tokyo, Bunkyo-ku, Japan (Ringgold ID: RIN13143)
,
Hiroyuki Takamaru 
3   Endoscopy Division, National Cancer Center Hospital, Chuo-ku, Japan (Ringgold ID: RIN68380)
,
Naoto Tamai
1   Department of Endoscopy, The Jikei University School of Medicine, Minato-ku, Japan (Ringgold ID: RIN12839)
,
Mitsuhiro Fujishiro 
2   Department of Gastroenterology, The University of Tokyo, Bunkyo-ku, Japan (Ringgold ID: RIN13143)
,
Yutaka Saito
3   Endoscopy Division, National Cancer Center Hospital, Chuo-ku, Japan (Ringgold ID: RIN68380)
,
Kazuki Sumiyama
1   Department of Endoscopy, The Jikei University School of Medicine, Minato-ku, Japan (Ringgold ID: RIN12839)
› Author AffiliationsSupported by: The Jikei University Collaborative Research Fund

Clinical Trial: Registration number (trial ID): UMIN000046522, Trial registry: UMIN Japan (http://www.umin.ac.jp/english/), Type of Study: Prospective, Randomized, Multi-Center Study
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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 mm<sup>2</sup>/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, ...)


Publication History

Received: 28 June 2024

Accepted after revision: 11 November 2024

Accepted Manuscript online:
10 March 2025

Article published online:
04 April 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

Bibliographical Record
Mamoru Ito, Yuko Miura, Yasuhiko Mizuguchi, Hiroto Furuhashi, Yosuke Tsuji, Hiroyuki Takamaru, Naoto Tamai, Mitsuhiro Fujishiro, Yutaka Saito, Kazuki Sumiyama. Efficacy and safety of multi-loop traction device-assisted colorectal endoscopic submucosal dissection: Multicenter randomized clinical trial. Endosc Int Open 2025; 13: a24660718.
DOI: 10.1055/a-2466-0718
 

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