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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-

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Early colon cancer,Colon adenoma
Date of first enrollment	2015/04/01
Target sample size	300
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	After colorectal ESD, enforce PGA felt + fibrin glue sealing method After colorectal ESD, do not enforce PGA felt + fibrin glue sealing method

Outcome(s)

Primary Outcome	Delayed bleeding
Secondary Outcome	- intraoperative bleeding - resection with a tumor-free margin rate - curative resection rate - en bloc resection rate - incidence of perioperative thromboembolic event

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude 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.