Unique ID issued by UMIN | UMIN000021410 |
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Receipt number | R000024563 |
Scientific Title | A multicenter randomized controlled study evaluating 20G needl with a core trap for EUS guided fine needle biopsy in diagnosis of gastric submucosal tumor |
Date of disclosure of the study information | 2016/04/01 |
Last modified on | 2022/03/14 09:36:14 |
A multicenter randomized controlled study evaluating 20G needl with a core trap for EUS guided fine needle biopsy in diagnosis of gastric submucosal tumor
The utility of 20G needl with a core trap for EUS guided fine needle biopsy in diagnosis of gastric submucosal tumor
A multicenter randomized controlled study evaluating 20G needl with a core trap for EUS guided fine needle biopsy in diagnosis of gastric submucosal tumor
The utility of 20G needl with a core trap for EUS guided fine needle biopsy in diagnosis of gastric submucosal tumor
Japan |
Gastoric submucosal tumor
Gastroenterology |
Malignancy
NO
In diagnoses of gastric submucosal tumors by EUS-FNA, 20G needle with a core trap is evaluated in terms of efficacy and safety
Safety,Efficacy
Rate of satisfactory sampling for histological diagnosis
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Diagnosis
Device,equipment |
EUS-FNA needle with a core trap
20 | years-old | <= |
Not applicable |
Male and Female
1. Gastoric submucosal tumors more than 10 mm
2. ECOG performance status = 1, 2
3. No severe dysfunction in other organs
4. Requirement of EUS-FNA for deciding surgical resection
5. Written informed consent obtained from patients
1. Presence of intervening vessels or other organs on the puncture line
2. High risk of complications (bleeding, tumor seeding)
3. Inability to obtain informed consent
50
1st name | Ken |
Middle name | |
Last name | Kamata |
Kinki University Faculty Medicine
Department of Gastroenterology and Hepatology
589-8511
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
072-366-0221
m-kitano@med.kindai.ac.jp
1st name | Ken |
Middle name | |
Last name | Kamata |
Kinki University Faculty Medicine
Department of Gastroenterology and Hepatology
589-8511
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
072-366-0221
ky11@leto.eonet.ne.jp
Osaka EUS-FNA Study Group
Kinki University Faculty Medicine
Self funding
Institutional Review Board of of Kindai University Faculty of Medicine
377-2,Ohno-Higashi,Osaka,Jpan
0723660221
zizen@med.kindai.ac.jp
NO
2016 | Year | 04 | Month | 01 | Day |
NA
Published
NA
50
The specimen collection rate for EUS-FNB was over 80%, indicating good performance.
2022 | Year | 03 | Month | 14 | Day |
g-SMT
Consecutive
Non
Sample collection rate
Completed
2016 | Year | 02 | Month | 09 | Day |
2016 | Year | 04 | Month | 28 | Day |
2016 | Year | 04 | Month | 01 | Day |
2020 | Year | 09 | Month | 01 | Day |
2016 | Year | 03 | Month | 09 | Day |
2022 | Year | 03 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024563
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