Unique ID issued by UMIN | UMIN000024184 |
---|---|
Receipt number | R000027790 |
Scientific Title | A pilot study of efficacy in endoscopic hand-suturing (EHS) for mucosal defects after endoscopic resection in cases with antithrombotic agents |
Date of disclosure of the study information | 2016/10/01 |
Last modified on | 2021/05/18 20:11:59 |
A pilot study of efficacy in endoscopic hand-suturing (EHS) for mucosal defects after endoscopic resection in cases with antithrombotic agents
A pilot study of efficacy in endoscopic hand-suturing (EHS) for mucosal defects after endoscopic resection in cases with antithrombotic agents
A pilot study of efficacy in endoscopic hand-suturing (EHS) for mucosal defects after endoscopic resection in cases with antithrombotic agents
A pilot study of efficacy in endoscopic hand-suturing (EHS) for mucosal defects after endoscopic resection in cases with antithrombotic agents
Japan |
Early gastric cancer, gastric adenoma
Gastroenterology |
Malignancy
NO
To assess the efficacy in endoscopic hand-suturing (EHS) for mucosal defects after endoscopic resection in cases with antithrombotic agents
Safety,Efficacy
the rate of postoperative bleeding within 4 weeks after endoscopic resection
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment | Maneuver |
After ESD for gastric tumors, we perform EHS for the mucosal defects. Blood examinations are performed on 1 and 3 POD, gastroendoscopy is performed on 3 POD. The patients are told to monitor whether bleeding occur within 4 weeks after discharge and we check them at outpatients clinic.
20 | years-old | <= |
Not applicable |
Male and Female
The antithrombotic agents users who have gastric tumors which are in indication of ESD and less than 3 cm
The cases that tumors are located at fornix, greater curvature of upper body or lesser curvature of angle in which it is difficult to perform EHS
30
1st name | Naohisa |
Middle name | |
Last name | Yahagi |
Keio University, School of Medicine
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
160-8582
35 Shinanomachi, Shinjuku-ku Tokyo 160-8582
03-3353-1211(61591)
yahagi.keio@gmail.com
1st name | Teppei |
Middle name | |
Last name | Akimoto |
Keio University, School of Medicine
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
160-8582
35 Shinanomachi, Shinjuku-ku Tokyo 160-8582
03-3353-1211(61591)
t-akimoto@nms.ac.jp
Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University, School of Medicine
NO
Self funding
Keio University Research Ethics Committee
35 Shinanomachi, Shinjuku-ku Tokyo 160-8582
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
NO
2016 | Year | 10 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 06 | Month | 13 | Day |
2016 | Year | 09 | Month | 27 | Day |
2016 | Year | 10 | Month | 01 | Day |
2019 | Year | 12 | Month | 01 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 07 | Month | 05 | Day |
2021 | Year | 03 | Month | 31 | Day |
2016 | Year | 09 | Month | 27 | Day |
2021 | Year | 05 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027790
Research Plan | |
---|---|
Registered date | File name |
2021/05/18 | プロトコール(EHS phase II) Ver.5(2020.11).docx |
Research case data specifications | |
---|---|
Registered date | File name |
2018/04/02 | CRF(EHS phase II) Ver.2(2017.9).docx |
Research case data | |
---|---|
Registered date | File name |
2021/05/18 | 022.pdf |