UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033028 |
|---|---|
| Receipt number | R000037655 |
| Scientific Title | Histologic diagnosis endoscopic ultrasound needles with and without franseen design :A randomized controlled trial |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2018/06/17 15:36:56 |
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Basic information
Public title
Histologic diagnosis endoscopic ultrasound needles with and without franseen design :A randomized controlled trial
Acronym
A randomized controlled trial for Endoscopic ultrasound-guided fine needle aspiration
Scientific Title
Histologic diagnosis endoscopic ultrasound needles with and without franseen design :A randomized controlled trial
Scientific Title:Acronym
A randomized controlled trial for Endoscopic ultrasound-guided fine needle aspiration
Region
| Japan |
Condition
Condition
Cases which needs histlogical diagnosis by EUS-FNA
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare histological diagnosis ability of with and without franseen needle
Basic objectives2
Others
Basic objectives -Others
quantitiy of sample
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy for histrogical diagnosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
EUS-FNA using standard needle
Interventions/Control_2
EUS-FNA using 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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
case which needs EUS-FNA
Key exclusion criteria
cystic disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Kida |
Organization
Kitasato university medical center
Division name
Department of gastroenterology
Zip code
Address
6-100 Arai kitamoto city Saitama
TEL
0485931212
uehara@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuho Uehara |
Organization
Kitasato university medical center
Division name
Department of gastroenterology
Zip code
Address
6-100 Arai kitamoto city Saitama
TEL
0485931212
Homepage URL
uehara@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato university medical center
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 | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 17 | Day |
Last modified on
| 2018 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037655
