Unique ID issued by UMIN | UMIN000034533 |
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Receipt number | R000038933 |
Scientific Title | Randomized controlled trial of the S-O clip application versus conventional method groups in endoscopic submucosal dissection (ESD) for gastric epithelial neoplasia |
Date of disclosure of the study information | 2018/10/17 |
Last modified on | 2020/04/20 23:07:41 |
Randomized controlled trial of the S-O clip application versus conventional method groups in endoscopic submucosal dissection (ESD) for gastric epithelial neoplasia
Randomized controlled trial of the S-O clip application versus conventional method groups in endoscopic submucosal dissection (ESD) for gastric epithelial neoplasia
Randomized controlled trial of the S-O clip application versus conventional method groups in endoscopic submucosal dissection (ESD) for gastric epithelial neoplasia
Randomized controlled trial of the S-O clip application versus conventional method groups in endoscopic submucosal dissection (ESD) for gastric epithelial neoplasia
Japan |
Early gastric cancer, Gastric adenoma
Gastroenterology |
Malignancy
NO
To evaluate the usefulness of the S-O clip for gastric endoscopic submucosal dissection (ESD)
Safety,Efficacy
Confirmatory
Pragmatic
ESD procedure time
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Device,equipment |
Traction-assisted ESD with S-O clip group
Conventional ESD group
20 | years-old | <= |
94 | years-old | >= |
Male and Female
1)Histopathologically proven gastric cancer or adenoma that meets the absolute or expanded indication of ESD according to the Japanese gastric cancer treatment guideline 2018 (5th edition)
2)No gastrectomy and reconstructive surgery of gastric tube for esophageal cancer
3)Eastern Cooperative Oncology Group Performance Status ranges from 0 to 2
4)Written informed consent by the patient
5)Patient age between 20 and 94 years
1)Pregnant patients or with the possibility of the pregnancy
2)Lactating patients
3)Patients disqualified for this study by the physician
80
1st name | Mitsuru |
Middle name | |
Last name | Nagata |
Shonan Fujisawa Tokushukai Hospital
Department of Endoscopy
253-0041
1-5-1 TUJIDOUKANDAI FUJISAWA-SHI KANAGAWA JAPAN
0466-35-1177
mitsuru10jp@yahoo.co.jp
1st name | Mitsuru |
Middle name | |
Last name | Nagata |
Shonan Fujisawa Tokushukai Hospital
Department of Endoscopy
253-0041
1-5-1 TUJIDOUKANDAI FUJISAWA-SHI KANAGAWA JAPAN
0466-35-1177
mitsuru10jp@yahoo.co.jp
Shonan Fujisawa Tokushukai Hospital
Shonan Fujisawa Tokushukai Hospital
Self funding
Mirai Iryo Research Center
1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
03-3263-4801
shimizu@mirai-iryo.com
YES
TGE01105-008
Mirai Iryo Research Center
湘南藤沢徳洲会病院(神奈川県)
2018 | Year | 10 | Month | 17 | Day |
Unpublished
Completed
2018 | Year | 10 | Month | 05 | Day |
2018 | Year | 10 | Month | 05 | Day |
2018 | Year | 10 | Month | 17 | Day |
2019 | Year | 09 | Month | 11 | Day |
2018 | Year | 10 | Month | 17 | Day |
2020 | Year | 04 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038933
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