gastric neoplasia
Conditions
Interventions
Covering mucosal defects after ESD with PGA sheets and fibrin glue.
Do not covering mucosal defects after ESD with PGA sheets and fibrin glue.
Sponsors
Nagasaki University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
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)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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dalayed bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| ?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 | — |
Countries
Japan
Outcome results
None listed