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A randomized controlled trial about the efficacy of colorectal ESD using a scissors-type knife with traction device for early colorectal neoplasms

A randomized controlled trial about the efficacy of colorectal ESD using a scissors-type knife with traction device for early colorectal neoplasms - RCT about the efficacy of colorectal ESD using a scissors-type knife with traction device

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040582
Enrollment
90
Registered
2020-05-29
Start date
2020-08-01
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

Early colorectal neoplasm

Interventions

Group A: C (Conventional)-ESD Group B: T (Traction)-ESD

Sponsors

Department of Gastroenterology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Lesions for which en bloc resection with snare EMR isdifficult to apply and tumor size is 20 to 50 mm. (2) Aged 20 to 90 years old. (3) PS (ECOG) performance status of 0,1or2. (4) Without regard to gender. (5) Patients taking one antithrombotic drug. (6) Written informed consent

Exclusion criteria

Exclusion criteria: (1) preorerative endoscopic diagnosis of tumor depth is cT1b(SM2). (2) The morphology of tumor is protruded. (3) Lesions of local recurrence after endoscopic resection. (4) Familial adenomatous polyposis and Inflamatory bowel disease. (5) Patients taking more than two kinds of antithrombotic drugs. (6) Patients with thrombocytopenia and/or bleeding tendency. (7) Women during pregnancy. (8) Patients enrolled in this study. (9) Unsuitable patient for clinical trial judged by clinicians.

Design outcomes

Primary

MeasureTime frame
the resected specimen area to the procedure time—

Secondary

MeasureTime frame
Resection Time En bloc resection rate Complete resection rate Curative resection rate Complication rate One-year residual recurrence rate Incidence of damage to resected specimens due to traction devices—

Countries

Japan

Contacts

Public ContactYuzuru Tamaru

National Hospital Organization Kure Medical Center and Chugoku Cancer Center Department of Gastroenterology

tamaru.yuzuru.vh@mail.hosp.go.jp+81-823-22-3111

Outcome results

None listed

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