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
- Conditions
- gastric neoplasia
- Registration Number
- JPRN-UMIN000013995
- Lead Sponsor
- agasaki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open public recruiting
- Sex
- All
- Target Recruitment
- 300
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.
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.
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method