UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032598 |
|---|---|
| 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 |
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Basic information
Public title
A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses
Acronym
Prospective study comparing 21-gaude and 22-gauge needles for EUS-FNA of pancreatic masses
Scientific Title
A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses
Scientific Title:Acronym
Prospective study comparing 21-gaude and 22-gauge needles for EUS-FNA of pancreatic masses
Region
| Japan |
Condition
Condition
solid pancreatic masses
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
Comparison of technical success, diagnostic performance for malignancy, the number of needle passes required to obtain a diagnosis, needle angle during puncture, and complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
EUS-FNA is performed with a novel 21-gauge needle (EUS Sonopsy CY, Hakko Medical).
Interventions/Control_2
EUS-FNA is performed with a standard 22-gauge needle (SonoTip ProControl, Medi-Globe GmbH)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a solid pancreatic mass who are planned to EUS-FNA
Key exclusion criteria
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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukitaka Yamashita |
Organization
Japanese Red Cross Wakayama Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
4-20, Komatsubara-dori, Wakayama, 640-8558, Japan
TEL
073-422-4171
y-yamashita@kankyo.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Minaga |
Organization
Japanese Red Cross Wakayama Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
4-20, Komatsubara-dori, Wakayama, 640-8558, Japan
TEL
073-422-4171
Homepage URL
kousukeminaga@yahoo.co.jp
Sponsor or person
Institute
Japanese Red Cross Wakayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
No Funding Source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 15 | Day |
Last modified on
| 2018 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037150
