Efficacy and Safety of Multi Loop Traction Device-assisted Colorectal Endoscopic Submucosal Dissection: A Multicenter, Randomized Clinical Trial

Efficacy and Safety of Multi Loop Traction Device-assisted Colorectal Endoscopic Submucosal Dissection: A Multicenter, Randomized Clinical Trial - Efficacy and Safety of Multi Loop Traction Device-assisted Colorectal Endoscopic Submucosal Dissection: A Multicenter, Randomized Clinical Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000046522

Enrollment

109

Registered

2022-02-01

Start date

2022-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal neoplasm

Interventions

1) MLTD-ESD group Colorectal endoscopic submucosal dissection (ESD) is performed using the Multi Loop Traction Device (MLTD). The number of MLTD used in a single session is not limited. The conver

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 20 years or older who undergo endoscopic submucosal dissection for superficial colorectal neoplasm with a tumor size of 20 mm or more

Exclusion criteria

Exclusion criteria: 1) Patients who do not give consent for the study 2) Patients whose lesions involve terminal ileum, appendiceal orifice, or diverticulum 3) Patients with recurrent lesions at the scar after endoscopic treatment 4) Patients who are not managed according to guidelines regarding perioperative withdrawal of antithrombotic therapy 5) Patients with severe organ failure 6) Patients with coagulopathy at high risk of bleeding 7) Patients who are pregnant 8) Patients with urgent and obvious life threatening situation 9) Patients who are judged unsuitable for participation by the doctors

Design outcomes

Primary

Measure	Time frame
Dissection speed (area resected [mm^2]/duration in minutes)	—

Secondary

Measure	Time frame
1) Overall treatment duration (min) 2) Technical success (%) 3) En bloc resection rate (%) 4) R0 resection rate (%) 5) Intraoperative perforation rate (%) 6) Delayed perforation rate (%) 7) Delayed bleeding rate (%)	—

Countries

Japan

Contacts

Public ContactHiroto Furuhashi

The Jikei University School of Medicine Department of Endoscopy

ms04furuhashi@jikei.ac.jp0336331111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026