NIPH Clinical Trials Search

UMIN ID: UMIN000013995

Registered date:01/06/2014

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-

Basic Information

Recruitment status Open public recruiting
Health condition(s) or Problem(s) studiedgastric neoplasia
Date of first enrollment2014/04/28
Target sample size300
Countries of recruitmentJapan
Study typeInterventional,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.


Primary Outcomedalayed 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 minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria1) 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 criteria1)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


public contact
Name Noyuki Yamaguchi
Address 1-7-1 Sakamoto,Nagasaki Japan
Telephone 095-819-7481
Affiliation Nagasaki University Hospital Department of GASTROENTEROLOGY and HEPATOLOGY,
scientific contact
Name Kazuhiko Nakao
Address 1-7-1 Sakamoto,Nagasaki Japan
Telephone 095-819-7482
Affiliation Nagasaki University Hospital Department of Gastroenterology and hepatology