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A prospective randomized study of two endo-knives for endoscopic submucosal dissection of colorectal neoplasm.

A prospective randomized study of two endo-knives for endoscopic submucosal dissection of colorectal neoplasm. - Randomized study of device for endoscopic submucosal dissection.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015762
Enrollment
52
Registered
2014-12-01
Start date
2014-12-01
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

Enrolled patients are enforced which groups of diveces Mucosectom2 group or SB knife Jr. at random. Enrolled patients are enforced which groups of physician Y.S. or D.T. at random. To allocate the si

Sponsors

Okayama University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Lesion diagnosed colorectum tumor. Lesion 20-50mm in diameter. Cancer including submucosal invasion less than 1mm. No lymph node or distant metastasis. Not matter wether prior biopsy or not.

Exclusion criteria

Exclusion criteria: Patients had severe organ failure for performed ESD Under 18 years. Patients disagreement.

Design outcomes

Primary

MeasureTime frame
Procedure time required for submucosal dissection of Mucosectom2 and SB knife. (The time is combined process of injection under the mucosa, of circular mucosal incision and of dissection of submucosa.)

Secondary

MeasureTime frame
Total procedure time for the lesions had fibrosis. Total procedure time for the lesions observed difficult. En block resection rate. Self-completion rates. Number of hemostatic therapy. Number of adverse events.

Countries

Japan

Contacts

Public ContactYuusaku Sugihara

Okayama University Graduate School of Medicine Department of gastroenterology and hepatology

y.sugi117@gmail.com086-235-7219

Outcome results

None listed

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