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The efficacy of endoscopic tissue shielding method with polyglycolic acid (PGA) sheets and fibrin glue for the prevention of delayed bleeding after colorectal endoscopic submucosal dissection in patients taking antithrombotic therapy. -multicenter randomized control study-

The efficacy of endoscopic tissue shielding method with polyglycolic acid (PGA) sheets and fibrin glue for the prevention of delayed bleeding after colorectal endoscopic submucosal dissection in patients taking antithrombotic therapy. -multicenter randomized control study- - The efficacy of endoscopic tissue shielding method with PGA sheets and fibrin glue for the prevention of delayed bleeding after colorectal endoscopic submucosal dissection in patients taking antithrombotic therapy. -multicenter randomized control study-

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016832
Enrollment
300
Registered
2015-04-01
Start date
2015-04-01
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 colon cancer,Colon adenoma

Interventions

After colorectal ESD, enforce PGA felt + fibrin glue sealing method After colorectal ESD, do not enforce PGA felt + fibrin glue sealing method

Sponsors

1-7-1 Sakamoto,Nagasaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Early colon cancer or adenoma with adaptation lesions of ESD in the patients on antithrombotic therapy. 2.There is no significant metastasis clinically. 3.The patients who have given written informed consent to this study, and age at the time of the agreement acquisition is 20 years or older.

Exclusion criteria

Exclusion criteria: 1. Patient who have double cancer (The cancer in situ or intramucosal carcinoma which can be cured completely by endoscopy operation, that is proper.) 2. Severe hepatic disorder, heart disease (myocardial infarction, angina, congestive heart failure, etc.), renal dysfunction 3. The patient who have severe infection. 4. Pregnant woman or with the possibility. The woman who is lactation period. 5. Severe bleeding or shock state 6. Patients with bleeding tendency. 7. Patients not elapsed patients or more than three months after the end of participating in another clinical trial. 8. Those who are considered to be inappropriate for this study by doctors.

Design outcomes

Primary

MeasureTime frame
Delayed bleeding

Secondary

MeasureTime frame
- intraoperative bleeding - resection with a tumor-free margin rate - curative resection rate - en bloc resection rate - incidence of perioperative thromboembolic event

Countries

Japan

Contacts

Public ContactN

Nagasaki University Hospital Department of GASTROENTEROLOGY and HEPATOLOGY

naoyuki3334@hotmail.com095-819-7489

Outcome results

None listed

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