Unique ID issued by UMIN | UMIN000037309 |
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Receipt number | R000042533 |
Scientific Title | A multicenter prospective randomized controlled study on number of to-and-fro movement at each puncture during endoscopic ultrasound-guided fine-needle aspiration of pancreatic masses: 3 vs. 12 to-and-fro movements |
Date of disclosure of the study information | 2019/09/01 |
Last modified on | 2023/11/14 06:35:56 |
A multicenter prospective randomized controlled study on number of to-and-fro movement at each puncture during endoscopic ultrasound-guided fine-needle aspiration of pancreatic masses: 3 vs. 12 to-and-fro movements
Study on number of to-and-fro movement during EUS-FNA
A multicenter prospective randomized controlled study on number of to-and-fro movement at each puncture during endoscopic ultrasound-guided fine-needle aspiration of pancreatic masses: 3 vs. 12 to-and-fro movements
Study on number of to-and-fro movement during EUS-FNA
Japan |
pancreatic tumor
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To assess whether the diagnostic ability of 3 strokes is not inferior to conventional 12 strokes during EUS-FNA using a 22G Franssen needle for pancreatic mass
Efficacy
Diagnostic sensitivity
1 Specificity, Accuracy, positive/negative predictive value
2 Sampling rate of macroscopically visible white tissue
3 Length of Macroscopically visible white specimen
4 Sampling rate of pathological tissue sample
5 Adverse Events
Interventional
Cross-over
Randomized
Individual
Single blind -participants are blinded
Active
2
Diagnosis
Maneuver |
3 to-and-fro movements during EUS-FNA
12 to-and-fro movements during EUS-FNA
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with pancreatic masses of 15 mm or larger in size by imaging (CT, MRI, PET, or EUS) and require pathological diagnosis
2) Age at the time of registration is over 20 years old
3) Patients obtained written informed consent after explanation about the study
1) ECOG Performance Status (PS) 4
2) Pregnancy or pregnancy is suspected.
3) A definitive diagnosis has already been made by other biopsy methods.
4) Platelet count less than 50,000 / microL
5) PT-INR 1.5 or more
6) The examination responsibility or the attending doctor judged it to be inappropriate for the subject
140
1st name | Yasuda |
Middle name | |
Last name | Ichiro |
University of Toyama
Third Department of Internal Medicine
930-0194
2630 Sugitani, Toyama city, Toyama prefecture, Japan
076-434-7301
yasudaich@gmail.com
1st name | Takahashi |
Middle name | |
Last name | Kosuke |
University of Toyama
Third Department of Internal Medicine
930-0194
2630 Sugitani, Toyama city, Toyama prefecture, Japan
076-434-7301
takapochi0809@gmail.com
University of Toyama
None
Other
Center for Clinical Reserch in Toyama University Hospital
2630 Sugitani, Toyama city, Toyama prefecture, Japan
076-415-8857
rinri@adm.u-toyama.ac.jp
NO
2019 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2019 | Year | 07 | Month | 03 | Day |
2019 | Year | 11 | Month | 21 | Day |
2019 | Year | 12 | Month | 01 | Day |
2021 | Year | 06 | Month | 30 | Day |
2019 | Year | 07 | Month | 08 | Day |
2023 | Year | 11 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042533
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