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A multicenter randomized controlled trial of post-ESD coagulation syndrome after colorectal endoscopic submucosal dissection

A multicenter randomized controlled trial of post-ESD coagulation syndrome after colorectal endoscopic submucosal dissection - RCT of PECS after colorectal ESD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058742
Enrollment
320
Registered
2025-08-20
Start date
2025-09-13
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 tumors 20mm - 50mm in diameter

Interventions

Group A: normal initiation group Group B: early initiation group

Sponsors

Department of Endoscopy, NHO Kure Medical Center and Chugoku Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients 1. with colorectal tumors measuring 20 - 50 mm in diameter considered difficult to remove en bloc with endoscopic mucosal resection, 2. aged 20 - 90 years at the time of obtaining informed consent, 3. with Eastern Cooperative Oncology Group performance status of 0 - 2, 4. with antithrombotic drug management according to the Japanese Guidelines for Gastroenterological Endoscopy, 5. who provided written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients with 1. colorectal tumors diagnosed as T1b cancer endospically, 2. colorectal tumors with local recurrence after endoscopic resection, 3. inflammatory bowel disease or familial adenomatous polyposis 4. a history of thrombocytopenia, coagulation system abnormalities, or bleeding tendency, 5. confirmed or possible pregnancy, 6. who have already enrolled in this study 7. unsuitable for clinical trial judged by clinicians

Design outcomes

Primary

MeasureTime frame
The proportion of post-ESD coagulation syndrome

Countries

Japan

Contacts

Public ContactYuzuru Tamaru

NHO Kure Medical Center and Chugoku Cancer Center Department of Endoscopy

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