Unique ID issued by UMIN | UMIN000012633 |
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Receipt number | R000014773 |
Scientific Title | Randomized cross-over clinical trial about the diagnositic accuracy of EUS-FNA for submucosal tumor; Comparison between needle with side reverse bevel and standard needle |
Date of disclosure of the study information | 2013/12/20 |
Last modified on | 2016/12/21 13:38:52 |
Randomized cross-over clinical trial about the diagnositic accuracy of EUS-FNA for submucosal tumor; Comparison between needle with side reverse bevel and standard needle
Randomized cross-over clinical trial about the diagnositic accuracy of EUS-FNA for submucosal tumor; Comparison between needle with side reverse bevel and standard needle
Randomized cross-over clinical trial about the diagnositic accuracy of EUS-FNA for submucosal tumor; Comparison between needle with side reverse bevel and standard needle
Randomized cross-over clinical trial about the diagnositic accuracy of EUS-FNA for submucosal tumor; Comparison between needle with side reverse bevel and standard needle
Japan |
Esophagial or gastric submucosal tumor
Gastroenterology |
Malignancy
NO
Comparison of diagnostic accuracy between a needle with side reverse bevel and a standard needle
Efficacy
Diagnositic accuracy
Interventional
Cross-over
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Diagnosis
Device,equipment |
GroupA: Puncture the lesion on the first and the third time with Procore (side reverse beveled) needle and on the second and the fourth time with Echo Tip Ultra (standard) needle
GroupB: Puncture the lesion on the second and the fourth time with Echo Tip Procore (side reverse beveled) needle and on the first and the third time with Echo Tip Ultra (standard) needle
20 | years-old | <= |
Not applicable |
Male and Female
1) Cases need histological or cytological diagnosis for treatment
2) Cases obtained written informed consent
1) Cases with high risk of puncturing cystic lesion
2) Cases with known bleeding disorders
3) Cases regarded by doctors as inappropriate for the enrollment for some reasons
20
1st name | |
Middle name | |
Last name | Mitsuhiro Kida |
Kitasato University School of Medicine
Gatroenterology
1-15-1 Kitasato Minami Sagamihara Kanagawa
042-778-8111
m-kida@kitasato-u.ac.jp
1st name | |
Middle name | |
Last name | Tomohisa Iwai |
Kitasato University School of Medicine
Gatroenterology
1-15-1 Kitasato Minami Sagamihara Kanagawa
042-778-8111
t-iwai@kitasato-u.ac.jp
Department of Gastroenterology Kitasato University School of Medicine
N/A
Self funding
NO
2013 | Year | 12 | Month | 20 | Day |
Unpublished
Completed
2013 | Year | 12 | Month | 01 | Day |
2014 | Year | 07 | Month | 01 | Day |
2017 | Year | 06 | Month | 30 | Day |
2017 | Year | 06 | Month | 30 | Day |
2013 | Year | 12 | Month | 20 | Day |
2016 | Year | 12 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014773
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