Unique ID issued by UMIN | UMIN000013995 |
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Receipt number | R000016306 |
Scientific Title | 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- |
Date of disclosure of the study information | 2014/06/01 |
Last modified on | 2016/07/05 16:15:10 |
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-
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-
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-
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-
Japan |
gastric neoplasia
Gastroenterology |
Malignancy
NO
To examine safety of ESD and efficacy of endoscopic tissue shielding method with PGA sheets and fibrin glue for the prevention of post-ESD bleeding in patients taking antiplatelet agents.
Safety,Efficacy
dalayed bleeding
・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
Parallel
Randomized
Open -no one is blinded
Placebo
2
Treatment
Medicine |
Covering mucosal defects after ESD with PGA sheets and fibrin glue.
Do not covering mucosal defects after ESD with PGA sheets and fibrin glue.
20 | years-old | <= |
Not applicable |
Male and Female
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.
300
1st name | |
Middle name | |
Last name | Kazuhiko Nakao |
Nagasaki University Hospital
Department of Gastroenterology and hepatology
1-7-1 Sakamoto,Nagasaki
095-819-7482
kazuhiko@nagasaki-u.ac.jp
1st name | |
Middle name | |
Last name | Noyuki Yamaguchi |
Nagasaki University Hospital
Department of GASTROENTEROLOGY and HEPATOLOGY,
1-7-1 Sakamoto,Nagasaki
095-819-7481
naoyuki3334@hotmail.com
Nagasaki University Hospital
none
Self funding
NO
長崎医療センター
佐世保共済病院
戸畑共立病院
大分大学病院
福岡大学筑紫病院
九州医療センター
佐賀県立医療センター好生館
済生会熊本病院
鹿児島大学病院
宮崎大学病院
嬉野医療センター
鳥取大学医学部附属病院
鳥取県立中央病院
鳥取赤十字病院
2014 | Year | 06 | Month | 01 | Day |
Unpublished
Open public recruiting
2014 | Year | 04 | Month | 04 | Day |
2014 | Year | 04 | Month | 28 | Day |
2014 | Year | 05 | Month | 19 | Day |
2016 | Year | 07 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016306
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