UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041676 |
|---|---|
| Receipt number | R000045969 |
| Scientific Title | EUS-FNB wit or without on-site evaluation for the diagnosis of pancreatic tumor using novel 22G FNB needle: Prospective randomized controlled trial |
| Date of disclosure of the study information | 2020/09/04 |
| Last modified on | 2020/09/04 07:54:50 |
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Basic information
Public title
EUS-FNB wit or without on-site evaluation for the diagnosis of pancreatic tumor using novel 22G FNB needle: Prospective randomized controlled trial
Acronym
EUS-FNB with or without ROSE using 22G FNB needle: H2O study
Scientific Title
EUS-FNB wit or without on-site evaluation for the diagnosis of pancreatic tumor using novel 22G FNB needle: Prospective randomized controlled trial
Scientific Title:Acronym
EUS-FNB with or without ROSE using 22G FNB needle: H2O study
Region
| Japan |
Condition
Condition
Pancreatic tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Diagnostic yield
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic yiled
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
rapid on-site evaluation(ROSE)
Interventions/Control_2
macroscopic on-site evaluation(MOSE)
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
pancreatic tumor
Performance status <3
Key exclusion criteria
contraindication of EUS-FNA
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical College
Division name
2nd Department of Internal Medicine
Zip code
569-8686
Address
2-7 Daigakuchou, Takatsukishi, Osaka 569-8686, Japan
TEL
072-683-1221
oguratakeshi0411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical College
Division name
2nd Department of Internal Medicine
Zip code
569-8686
Address
2-7 Daigakuchou, Takatsukishi, Osaka 569-8686, Japan
TEL
072-683-1221
Homepage URL
oguratakeshi0411@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
Osaka Medical College
Address
2-7 Daigakuchou, Takatsukishi, Osaka 569-8686, Japan
Tel
072-683-1221
oguratakeshi0411@yahoo.co.jp
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
| 2020 | Year | 09 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 04 | Day |
Last modified on
| 2020 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045969
