Unique ID issued by UMIN | UMIN000032598 |
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Receipt number | R000037150 |
Scientific Title | A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses |
Date of disclosure of the study information | 2018/05/25 |
Last modified on | 2018/09/29 22:50:41 |
A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses
Prospective study comparing 21-gaude and 22-gauge needles for EUS-FNA of pancreatic masses
A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses
Prospective study comparing 21-gaude and 22-gauge needles for EUS-FNA of pancreatic masses
Japan |
solid pancreatic masses
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To compare the performance characteristics and safety of newly designed 21-gauge needle versus standard 22-gauge aspiration needle for the diagnosis of solid pancreatic masses.
Safety,Efficacy
Comparison of diagnostic yield (sample cellularity and bloodiness) of the FNA samples between newly designed 21-gauge and standard 22-gauge needles for solid pancreatic masses
Comparison of technical success, diagnostic performance for malignancy, the number of needle passes required to obtain a diagnosis, needle angle during puncture, and complications
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
YES
2
Diagnosis
Device,equipment |
EUS-FNA is performed with a novel 21-gauge needle (EUS Sonopsy CY, Hakko Medical).
EUS-FNA is performed with a standard 22-gauge needle (SonoTip ProControl, Medi-Globe GmbH)
20 | years-old | <= |
Not applicable |
Male and Female
Patients with a solid pancreatic mass who are planned to EUS-FNA
1. Patients with ECOG Performance status 4
2. Patients with bleeding tendency (prothrombin time international normalized ratio >1.5, platelets <50000)
3. Patients with pancreatic mass which cannot be visualized on EUS
4. Patients younger than 20 years old
5. Patients who do not agree to participate in this study
100
1st name | |
Middle name | |
Last name | Yukitaka Yamashita |
Japanese Red Cross Wakayama Medical Center
Department of Gastroenterology and Hepatology
4-20, Komatsubara-dori, Wakayama, 640-8558, Japan
073-422-4171
y-yamashita@kankyo.ne.jp
1st name | |
Middle name | |
Last name | Kosuke Minaga |
Japanese Red Cross Wakayama Medical Center
Department of Gastroenterology and Hepatology
4-20, Komatsubara-dori, Wakayama, 640-8558, Japan
073-422-4171
kousukeminaga@yahoo.co.jp
Japanese Red Cross Wakayama Medical Center
No Funding Source
Other
NO
2018 | Year | 05 | Month | 25 | Day |
Unpublished
A total of 93 patients (40.9 % female; mean age 70.1 years) underwent EUS-FNA with the novel 21-gauge needle (n = 47) or the standard 22-gauge needle (n = 46). Baseline characteristics did not differ between the groups. The technical success rate was 100% in both groups, and the overall diagnostic accuracy for malignancy was similar between the groups (100 % in the 21-gauge group vs. 95.7% in the 22-gauge group, P = 0.242). Nevertheless, the 21-gauge needle resulted in significantly higher scores for cellularity (P = 0.010), and lower scores for blood contamination (P < 0.001). The median number of needle passes using the 21-gauge needle was less as compared to the 22-gauge needle (2 and 3, respectively, P = 0.003). The needle angle during puncture was more restricted in the 21-gauge needle (P < 0.001). Procedure-related complication rate was not different between the groups (P = 0.148).
Completed
2014 | Year | 05 | Month | 15 | Day |
2014 | Year | 06 | Month | 01 | Day |
2017 | Year | 06 | Month | 30 | Day |
2017 | Year | 12 | Month | 31 | Day |
2018 | Year | 01 | Month | 31 | Day |
2018 | Year | 06 | Month | 30 | Day |
2018 | Year | 05 | Month | 15 | Day |
2018 | Year | 09 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037150
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