Unique ID issued by UMIN | UMIN000018359 |
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Receipt number | R000021254 |
Scientific Title | A multicenter prospective comparative crossover trial of endoscopic ultrasound-guided fine-needle aspiration between with and without the needle stylet using with the 22 gauge fine-needle aspiration needle |
Date of disclosure of the study information | 2015/07/20 |
Last modified on | 2018/07/23 08:39:52 |
A multicenter prospective comparative crossover
trial of endoscopic ultrasound-guided
fine-needle aspiration between with and
without the needle stylet using with the
22 gauge fine-needle aspiration needle
Comparative crossover trial of EUS-FNA with
and without stylet
A multicenter prospective comparative crossover
trial of endoscopic ultrasound-guided
fine-needle aspiration between with and
without the needle stylet using with the
22 gauge fine-needle aspiration needle
Comparative crossover trial of EUS-FNA with
and without stylet
Japan |
Pancreatic solid masses detected by imaging examination
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate histological tissue acquisition rate, quality of tissue, accuracy between EUS-FNA with and without stylet
Efficacy
Confirmatory
Not applicable
Accuracy
Cellularity of tissue obtained
Quality of tissue obtained
Adequate quality
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Diagnosis
Device,equipment | Maneuver |
At first and third aspiration,EUSFNA
with stylet is
performed. At second and forth
aspiration, EUS-FNA without stylet is performed.
At first and third aspiration,EUSFNA
without stylet is performed. At second
and forth aspiration, EUS-FNA with stylet is performed.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with solid pancreatic mass,
which can be punctured from stomach
or duodenum using 22G safely.
2) Patients consent to be included in the
study based on his/her own free will
after sufficient informing and
understanding of the study.
1) Cases in Perfomance status 4
2)Cases with sever complication in
other organs except original disease
(ASA classification more than 3)
3)Cases having impossibility of
cessation of anticoagulant
4)Cases with pregnancy or suspect of
pregnancy
5)Cases having difficulty in endoscopic
approach
6)Cases with definite diagnosis by
another biopsy
7) Cases having difficulty in
visualization of mass on EUS
8)Cases judged by principal investigator
to be inadequate as subjects
100
1st name | |
Middle name | |
Last name | Takao Itoi |
Tokyo Medical University
Department of Gastroenterology and Hepatology
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
03-3342-6111
itoitakao@gmail.com
1st name | |
Middle name | |
Last name | Shuntaro Mukai |
Tokyo Medical University
Department of Gastroenterology and Hepatology
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
03-3342-6111
maezora1031@yahoo.co.jp
Tokyo Medical University
Department of Gastroenterology and Hepatology
None
Self funding
National Cancer Center Hospital
Endoscopy division
NO
2015 | Year | 07 | Month | 20 | Day |
Unpublished
Completed
2015 | Year | 07 | Month | 20 | Day |
2015 | Year | 07 | Month | 20 | Day |
2017 | Year | 07 | Month | 20 | Day |
2015 | Year | 07 | Month | 20 | Day |
2018 | Year | 07 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021254
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