UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022813 |
|---|---|
| Receipt number | R000026196 |
| Scientific Title | Prospective evaluation of 20G core needle for EUS-guided histology of pancreatic tumor |
| Date of disclosure of the study information | 2016/06/22 |
| Last modified on | 2018/12/04 21:15:51 |
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Basic information
Public title
Prospective evaluation of 20G core needle for EUS-guided histology of pancreatic tumor
Acronym
Prospective evaluation of 20G core needle for EUS-guided histology of pancreatic tumor
Scientific Title
Prospective evaluation of 20G core needle for EUS-guided histology of pancreatic tumor
Scientific Title:Acronym
Prospective evaluation of 20G core needle for EUS-guided histology of pancreatic tumor
Region
| Japan |
Condition
Condition
Pancreatic neoplasm
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the quality of histological specimen obtained by 20G core needle
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of histology
Key secondary outcomes
The accuracy rate of histology and cytology, The success rate of EUS-FNA, Feasibility of immunohistochemical analysis, the incidence of adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1) Pancreatic tumor in size >10mm
2) age >20
Key exclusion criteria
1) Performance status 4
2) Pregnant woman
3) Platelet count <50,000/mm3
4) PT-international normalized ratio >1.5 or
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Ishiwatari |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
Address
1007 Shimonagakubo Nagaizumicho Suntogun Shizuoka
TEL
055-989-5222
ishihiro481019@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Ishiwatari |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
Address
1007 Shimonagakubo Nagaizumicho Suntogun Shizuoka
TEL
055-989-5222
Homepage URL
ishihiro481019@gmail.com
Sponsor or person
Institute
Division of Endoscopy, Shizuoka Cancer Center
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
| 2016 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 06 | Month | 21 | Day |
Last modified on
| 2018 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026196
