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A randomised controlled trial of the efficacy and safety of the Multi Loop Traction Device (MLTD) compared with the clip-with-line traction method in endoscopic submucosal dissection (ESD) for gastric neoplasia.

A randomised controlled trial of the efficacy and safety of the Multi Loop Traction Device (MLTD) compared with the clip-with-line traction method in endoscopic submucosal dissection (ESD) for gastric neoplasia. - MLTD trial2

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056611
Enrollment
150
Registered
2025-01-01
Start date
2025-01-01
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

gastric neoplasia

Interventions

Traction with MLTD Traction with clip-with-line

Sponsors

Kitasato University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 years of age or older 2. Early-stage gastric cancer or gastric adenoma that is an absolute indication, an expanded indication, or a relative indication as an alternative treatment according to the 6th edition of the Gastric Cancer Treatment Guidelines, and in which the tumor is located in the upper third or middle third of the stomach (U or M region in the 15th edition of the Japanese Gastric Cancer Association's "Gastric Cancer Treatment Guidelines"). 3. Cases in which the patient has given written informed consent after fully understanding the subject of the study.

Exclusion criteria

Exclusion criteria: 1. Cases of post-gastrectomy 2. Cases where consent for this study cannot be obtained 3. Cases with active infection, pregnancy or breastfeeding, serious mental illness, on steroid treatment, within 6 months of myocardial infarction, angina within 3 weeks, serious lung disease requiring oxygen inhalation, poorly controlled hypertension or diabetes. 4. Other cases deemed inappropriate by the investigator.

Design outcomes

Primary

MeasureTime frame
Dissection speed in ESD

Countries

Japan

Contacts

Public ContactGen Kitahara

Department of Gastroenterology, Kitasato University School of Medicine Department of Gastroenterology, Kitasato University School of Medicine

genkit@kitasato-u.ac.jp042-778-8111

Outcome results

None listed

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