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

UMIN ID: UMIN000013995

Registered date:01/06/2014

Basic Information

• Recruitment status: Open public recruiting
• Health condition(s) or Problem(s) studied: gastric neoplasia
• Date of first enrollment: 2014/04/28
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional,observational

Intervention(s)

Covering mucosal defects after ESD with PGA sheets and fibrin glue.
Do not covering mucosal defects after ESD with PGA sheets and fibrin glue.

Outcome(s)

• Primary Outcome: dalayed bleeding

Secondary Outcome

･intraoperative bleeding
･en bloc resection rate
･resection with a tumor-free margin rate
･curative resection rate
･remaining period and remaining rate of PGA sheets
･incidence of perioperative thromboembolic event

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female

Include criteria

1) The patients on antiplatelet therapy who will undergo ESD of gastric neoplasms.
2) Early gastric cancer based on its absolute indication and extended indication criteria.

3) There is no significant metastasis clinically.
4) 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.
5) In principle, the antiplatelet agent is low dose aspirin(LDA) only. In the case of the patients who are received multidrug therapy, they are displaceable to LDA only.

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)Patient with the following serious complications
･severe hepatic dysorder
･severe heart disease(myocardial infarction,angina,congestive heart failure)
･severe 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 who have not passed more than three months after the end or are participating in the another clinical study.
8)Those who are considered to be inappropriate for this study by doctors.

Related Information

• Primary Sponsor: Nagasaki University Hospital
• Source(s) of Monetary Support: none