Unique ID issued by UMIN | UMIN000035905 |
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Receipt number | R000039650 |
Scientific Title | Randomized controled trial of effect of number of strokes within targeted lesion during EUS-FNA. |
Date of disclosure of the study information | 2019/02/18 |
Last modified on | 2019/03/20 12:34:01 |
Randomized controled trial of effect of number of strokes within targeted lesion during EUS-FNA.
Effect of number of strokes within targeted lesion during EUS-FNA
Randomized controled trial of effect of number of strokes within targeted lesion during EUS-FNA.
Effect of number of strokes within targeted lesion during EUS-FNA
Japan |
pancreatic lesions which require histological diagnosis by EUS-FNA
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To investigate effects of number of strokes within targeted lesion on quality of histological specimens obtaned by EUS-FNA
Safety,Efficacy
Confirmatory
Others
Phase III
Histological quality and quantity in macroscopic whitish specimen.
Histological quality and quantity in macroscopic reddish specimen.
Cytological quality and quantity
Success rate of EUS-FNA procedure
Adverse events
Diagnostic accuracy of EUS-FNA
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Dose comparison
NO
Institution is not considered as adjustment factor.
Central registration
2
Diagnosis
Maneuver |
30 times of stroke of needle within targeted lesion
10 times of stroke of needle within targeted lesion
20 | years-old | <= |
Not applicable |
Male and Female
1. Lesion that require histological interpretation to obtain defenitive diagnosis
2. Age >=20 y
3. Ability to understand and willingness to sign a written statement of informed consent
1. Cystic lesion without solid component which can be punctured by EUS-FNA procedure
2. Difficult to visualize targeted lesion due to surgically altered anatomy etc.
3. Bleedinfg tendency
4. ASA >=3
5. ECOG PS >=4
6. Severe heart or plumonary disease
7. Pregnant or possibly pregnant women
8. Any disorder that compromised the patient's ability to provide written informed consent and/or comply with the study procedure
160
1st name | |
Middle name | |
Last name | Tsuyoshi Hayashi |
Teine Keijinkai Hospital
Center for Gastroenterology
1-40, 12-chome, 1-jou, Maeda, Teine-ku, Sapporo 006-8555, Hokkaido, Japan
011-681-8111
thayashi244@gmail.com
1st name | |
Middle name | |
Last name | Tsuyoshi Hayashi |
Teine Keijinkai Hospital
Center for Gastroenterology
1-40, 12-chome, 1-jou, Maeda, Teine-ku, Sapporo 006-8555, Hokkaido, Japan
011-681-8111
thayashi244@gmail.com
Center for Gastroenterology, Teine Keijinkai Hospital
Center for Gastroenterology, Teine Keijinkai Hospital
Self funding
NO
00
Teine Keijinkai Hospital
2019 | Year | 02 | Month | 18 | Day |
Unpublished
Terminated
2019 | Year | 02 | Month | 01 | Day |
2019 | Year | 01 | Month | 15 | Day |
2019 | Year | 02 | Month | 18 | Day |
2019 | Year | 02 | Month | 18 | Day |
2019 | Year | 02 | Month | 17 | Day |
2019 | Year | 03 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039650
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