UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034596 |
|---|---|
| Receipt number | R000039063 |
| Scientific Title | A prospective randomized controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid pancreatic masses |
| Date of disclosure of the study information | 2018/10/22 |
| Last modified on | 2021/04/23 12:33:10 |
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Basic information
Public title
A prospective randomized controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid pancreatic masses
Acronym
A prospective randomized controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid pancreatic masses
Scientific Title
A prospective randomized controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid pancreatic masses
Scientific Title:Acronym
A prospective randomized controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid 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 demonstrate the non-inferiority of the endoscopic ultrasound-guided tissue acquisition of 25-G Franseen needle comparing with 22-G Franseen needle in solid pancreatic masses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The tissue collection rate in each needle (cellularity score: 3,4,5)
Key secondary outcomes
1)Histological core collection rate in each needle(cellularity score: 5)
2)The tissue collection rate based on the tumor size, location, puncture rout and each pancreatic disease
3)Onsite diagnostic adequacy in each needle
4)Diagnostic accuracy in each needle
5)Specimen bloodiness in each needle
6)Ease of puncture in each needle
7)Needle visibility in each needle
8)Technical success rate in each needle
9)Adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
In EUS-FNA, 1st puncture using 25-G Franseen needle and 2nd puncture using 22-G Franseen needle.
Interventions/Control_2
In EUS-FNA, 1st puncture using 22-G Franseen needle and 2nd puncture using 25-G Franseen needle.
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 solid pancreatic masses who are referred to EUS-FNA
Key exclusion criteria
1)Patients with Performance status 4
2)Patients who have risk of bleeding, or with platelet count less than fifty thousand/mm2
3)Patients with anti-thrombotic agent 2 or more
4)Patients with pancreatic mass which we cannot detect by EUS
5)Pregnant woman
6)Patients less than 20 years old
7)Patients who do not agree to participate in this study
8)Patients who determined to be inappropriate
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironari Kato |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-4-1 Shikata-cho Kita-ku Okayama-city Okayama
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Tomoda |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
Homepage URL
tomotake79@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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 | 10 | Month | 22 | 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
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
| 2018 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 23 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 20 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039063
