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The Efficacy and Safety of SB Knife Jr. for Colorectal Endoscopic Submucosal Dissection (ESD) -International Multicenter Prospective Observational Study of existing treatment-

The Efficacy and Safety of SB Knife Jr. for Colorectal Endoscopic Submucosal Dissection (ESD) -International Multicenter Prospective Observational Study of existing treatment- - SB-INT ESD study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000031511
Enrollment
400
Registered
2018-02-28
Start date
2018-03-01
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 neoplasms

Interventions

None listed

Sponsors

National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: We aim to recruit 400 consecutive patients who will be performed ESD with SB knife Jr. for early colorectal neoplasms. Indications for colorectal ESD were based on the Criteria of Indications for Colorectal ESD proposed by the JGES guidelines for colorectal endoscopic submucosal dissection/endoscopic mucosal resection. Written informed consent for the inclusion in this study will be obtained from each patient prior to recruitment.

Exclusion criteria

Exclusion criteria: - pregnancy - age of less than 18 - failure to provide written informed consent - Others who are deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigators.

Design outcomes

Primary

MeasureTime frame
adverse events during the procedure (perforation)

Countries

Japan,Asia(except Japan),Europe

Contacts

Public ContactToshio Kuwai

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

kuwai.toshio.ur@mail.hosp.go.jp+81-823-22-3111

Outcome results

None listed

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