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A prospective study investigating the efficacy and safety of traction-band-assisted endoscopic closure for mucosal defect after colorectal endoscopic submucosal dissection: A multi-center trial (TBEC Trial)

A prospective study investigating the efficacy and safety of traction-band-assisted endoscopic closure for mucosal defect after colorectal endoscopic submucosal dissection: A multi-center trial (TBEC Trial) - TBEC Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047953
Enrollment
34
Registered
2022-06-05
Start date
2022-06-06
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

Traction-band-assisted endoscopic closure (TBEC) for mucosal defect after colorectal ESD

Sponsors

Kitakyushu Municipal Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Presence of colorectal neoplasms with 20-50mm in size diagnosed by endoscopy and capable of undergoing ESD as a local treatment (2)Lesions diagnosed as colorectal adenomas or adenocarcinomas (cT1a) (3)20 years old or more (4)Performance Status: 0, 1, 2 (5)Informed consent is obtained

Exclusion criteria

Exclusion criteria: (1)Lesions spreading to the Bauhin bulb or appendix (2)Lesions spreading to the diverticulum (3)Lesions located at the lower rectum (4)Currently undergoing dialysis (5)Requiring continuous administration of heparin during the perioperative period. (6)Patients taking steroids or immunosuppressive drugs (7)Those with contraindications for endoscopy (8)Patients judged to be inappropriate for the study by the attending physician in this trial

Design outcomes

Primary

MeasureTime frame
Complete closure of mucosal defect

Secondary

MeasureTime frame
The number of traction device and clip required, closure time, ESD procedure time, en bloc resection, complete resection, curative resection, adverse events

Countries

Japan

Contacts

Public ContactYorinobu Sumida

Kitakyushu Municipal Medical Center Department of Gastroenterology

y.raisin@gmail.com0935411831

Outcome results

None listed

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