Unique ID issued by UMIN | UMIN000008120 |
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Receipt number | R000009547 |
Scientific Title | The evaluation of Endoscopic Ultrasound-Guided Fine-needle Aspiration Using newly designed 22G Aspiration Needle with side port. -The Prospective Randomized, Controlled Trial of EUS-FNA Using 22G FNA needle with or without side port for Solid Pancreatic mass- |
Date of disclosure of the study information | 2012/07/01 |
Last modified on | 2016/06/07 09:49:38 |
The evaluation of Endoscopic Ultrasound-Guided Fine-needle Aspiration Using newly designed 22G Aspiration Needle with side port.
-The Prospective Randomized, Controlled Trial of EUS-FNA Using 22G FNA needle with or without side port for Solid Pancreatic mass-
The Prospective Randomized, Controlled Trial of EUS-FNA Using 22G Aspiration needle with or without side port for Solid Pancreatic mass.
The evaluation of Endoscopic Ultrasound-Guided Fine-needle Aspiration Using newly designed 22G Aspiration Needle with side port.
-The Prospective Randomized, Controlled Trial of EUS-FNA Using 22G FNA needle with or without side port for Solid Pancreatic mass-
The Prospective Randomized, Controlled Trial of EUS-FNA Using 22G Aspiration needle with or without side port for Solid Pancreatic mass.
Japan |
solid pancreatic mass
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the accuracy of EUS-FNA using newly designed FNA needle with side port.
Efficacy
accuracy rate
complication rate
number of puncture
Quality of the specimen
Interventional
Parallel
Randomized
Cluster
Single blind -participants are blinded
Active
YES
NO
Institution is considered as a block.
YES
Central registration
2
Prevention
Device,equipment |
With side port group
EUS-FNA using EZ shot 2 with side port (NA-230H-8022)
Without side port group
EUS-FNA using EZ shot 2 without side port (NA-220H-8022)
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients who have pancreatic mass which is detected by EUS.
2) age>20
3) Patients who understand and are willing to give a written informed consent about participation
1) Patients with performance status 4.
2) Patients with ASA scores greater than or equal to 3.
3) Patients who receive anticoagulant agent.
4) Women suspected of being pregnant
5) Histologically confirmed by other methods.
6) Platelets is lower than 50,000/mm3.
7) INR PT (Prothrombin time) is higher than 1.5.
8) Patients who are judged inappropriate by chief (responsive) medical examiner.
160
1st name | |
Middle name | |
Last name | Hirotoshi Ishiwatari |
Sapporo Medical University
The 4th department of internal medicine
Minami 1-jo, Nishi 16-chome, Chuoku, Sapporo, Hokkaido
011-611-2111
ishihiro@sapmed.ac.jp
1st name | |
Middle name | |
Last name | Michihiro no |
Sapporo Medical University
The 4th department of internal medicine
Minami 1-jo, Nishi 16-chome, Chuoku, Sapporo, Hokkaido
011-611-2111
ishihiro@sapmed.ac.jp
The 4th department of Internal Medicine, Sapporo Medical University.
The 4th department of Internal Medicine, Sapporo Medical University.
Self funding
NO
2012 | Year | 07 | Month | 01 | Day |
Published
Main results already published
2012 | Year | 07 | Month | 01 | Day |
2013 | Year | 01 | Month | 01 | Day |
2012 | Year | 06 | Month | 07 | Day |
2016 | Year | 06 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009547
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