Unique ID issued by UMIN | UMIN000025125 |
---|---|
Receipt number | R000028889 |
Scientific Title | A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia. |
Date of disclosure of the study information | 2016/12/30 |
Last modified on | 2019/06/09 09:36:52 |
A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.
A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.
A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.
A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.
Japan |
early gastric cancer/gastric adenoma
Gastroenterology |
Malignancy
NO
To evaluate the efficacy and safety of traction ESD with the S-O clip compared with conventional ESD in terms of procedure time for patients with gastric epithelial neoplasia
Safety,Efficacy
Confirmatory
Pragmatic
ESD procedure time
Adverse events(delayed bleeding/perforation), ESD procedure time according to the location of the lesion, the proficiency of the operator (trainee or expert)and the presence of ulcer findings; en bloc resection rate; complete en bloc resection rate; amount of submucosal injection
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
NO
Central registration
2
Treatment
Device,equipment |
A: traction ESD with the S-O clip group
B: Conventional ESD group
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically proven gastric adenoma or cancer, which is within the absolute or expanded indication of ESD according to Japanese gastric cancer treatment guideline 2014.
2) No gastrectomy and no reconstructive surgery of gastric tube for esophageal cancer.
3) Aged 20 years old or more.
4) ECOG performance status of 0, 1 or 2.
5) Predicted line of mucosal incision is not on the EG junction.
6) Predicted line of mucosal incision is not on the pylorus.
7) Follow up for 60 days after ESD.
8) Written informed consent.
1) Patients who are disqualified for this study by physicians
2) Patients with the possibility of the pregnancy or the pregnancy
3) Patients who are lactating
90
1st name | |
Middle name | |
Last name | Dai Hirasawa |
Sendai Kousei Hospital
Department of Gastroenterology
Hirose-cho 4-15, Aoba-ku, Sendai city, Miyagi, Japan
022-222-6181
hirasawa@sendai-kousei-hospital.jp
1st name | |
Middle name | |
Last name | Rintaro Hashimoto |
Sendai Kousei Hospital
Department of Gastroenterology
Hirose-cho 4-15, Aoba-ku, Sendai city, Miyagi, Japan
022-222-6181
rhashimoto@sendai-kousei-hospital.jp
Sendai Kousei Hospital
Sendai Kousei Hospital
Self funding
NO
仙台厚生病院
2016 | Year | 12 | Month | 30 | Day |
Unpublished
Completed
2016 | Year | 11 | Month | 30 | Day |
2017 | Year | 02 | Month | 01 | Day |
2016 | Year | 12 | Month | 30 | Day |
2017 | Year | 08 | Month | 31 | Day |
2016 | Year | 12 | Month | 02 | Day |
2019 | Year | 06 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028889