UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019827 |
|---|---|
| Receipt number | R000022907 |
| Scientific Title | Compassion of diagnostic yield between novel 21G and 19G FNA needle with core trap: randomized controlled trial |
| Date of disclosure of the study information | 2015/11/30 |
| Last modified on | 2017/05/19 13:54:39 |
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Basic information
Public title
Compassion of diagnostic yield between novel 21G and 19G FNA needle with core trap: randomized controlled trial
Acronym
Compassion of diagnostic yield between novel 21G and 19G FNA needle with core trap: randomized controlled trial
Scientific Title
Compassion of diagnostic yield between novel 21G and 19G FNA needle with core trap: randomized controlled trial
Scientific Title:Acronym
Compassion of diagnostic yield between novel 21G and 19G FNA needle with core trap: randomized controlled trial
Region
| Japan |
Condition
Condition
Tumor lesions
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Adequate sample for histological diagnosis
Basic objectives2
Others
Basic objectives -Others
Accuracy rate
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adequate sample for histological diagnosis
Key secondary outcomes
Accuracy rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
19G Fine needle
Interventions/Control_2
21G Fine 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 who are needed to perform EUS-FNA for diagnosis
Key exclusion criteria
Under 20 year old, pregnancy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Ogura |
Organization
Osaka Medical College
Division name
Second Department of Internal Medicine
Zip code
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
+81-527626111
oguratakeshi0411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Ogura |
Organization
Osaka Medical College
Division name
Second Department of Internal Medicine
Zip code
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
+81-527626111
Homepage URL
oguratakeshi0411@yahoo.co.jp
Sponsor or person
Institute
Takeshi Ogura
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 11 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 30 | 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
| 2015 | Year | 11 | Month | 17 | Day |
Last modified on
| 2017 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022907
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
