Unique ID issued by UMIN | UMIN000038140 |
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Receipt number | R000043472 |
Scientific Title | A multi-centered phase II study of efficacy in endoscopic HAND Suturing (EHS) Of Mucosal defects after Gastric Endoscopic submucosal dissection in patients with anti-thrombotic agents |
Date of disclosure of the study information | 2019/11/01 |
Last modified on | 2024/03/04 22:07:06 |
A multi-centered phase II study of efficacy in endoscopic HAND Suturing (EHS) Of Mucosal defects after Gastric Endoscopic submucosal dissection in patients with anti-thrombotic agents
Multi-centered Phase II trial on endoscopic hand suturing after gastric ESD in patients with antithrombotic agents
A multi-centered phase II study of efficacy in endoscopic HAND Suturing (EHS) Of Mucosal defects after Gastric Endoscopic submucosal dissection in patients with anti-thrombotic agents
G-HANDSOME phase II study
Japan |
Early gastric cancers
Gastroenterology |
Malignancy
NO
To evaluate the efficacy of endoscopic hand suturing after gastric endoscopic submucosal dissection in patients with antithrombotic agents
Efficacy
Delayed bleeding rate in postoperative week 3-4
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
Endoscopic hand suturing
20 | years-old | <= |
100 | years-old | >= |
Male and Female
1)A single early gastric cancer, 3cm or less
2)A candidate for ESD
3)Patients taking Antithrombotic agents continuously
4)Patients with the higher risk of thrombotic events compared to the risk of postoperative bleeding
5)20 years old or more
6)PS 0-1
7)Informed consent obtained
1)Lesions in remnant stomach after surgery
2)Patients with bleeding tendency
3)Liver cirrhosis (Child-Pugh B-C)
4)Chronic kidney disease on hemodialysis
5)Past history of endoscopic treatment within 1 month
6)Inappropriate cases for the recruitment suggested by doctors in charge
48
1st name | Osamu |
Middle name | |
Last name | Goto |
Nippon Medical School Hospital
Gastroenterology and Hepatology
113-8603
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
0338222131
o-goto@nms.ac.jp
1st name | Osamu |
Middle name | |
Last name | Goto |
Nippon Medical School
Gastroenterology and Hepatology
113-8603
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
0338222131
o-goto@nms.ac.jp
Nippon Medical School
Self funding
Self funding
Nippon Medical School Hospital Center for Clinical Research
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
0338222131
inq-ccr@nms.ac.jp
NO
2019 | Year | 11 | Month | 01 | Day |
Unpublished
49
Completed
2019 | Year | 09 | Month | 27 | Day |
2021 | Year | 04 | Month | 05 | Day |
2021 | Year | 04 | Month | 10 | Day |
2023 | Year | 08 | Month | 31 | Day |
2023 | Year | 10 | Month | 02 | Day |
2019 | Year | 09 | Month | 27 | Day |
2024 | Year | 03 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043472
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