UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012631 |
|---|---|
| Receipt number | R000014758 |
| Scientific Title | Randomized cross-over clinical trial about the diagnostic accuracy of EUS-FNA for pancreatic tumor; Comparison between needle with side reverse bevel and standard needle |
| Date of disclosure of the study information | 2013/12/20 |
| Last modified on | 2016/12/21 13:37:25 |
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Basic information
Public title
Randomized cross-over clinical trial about the diagnostic accuracy of EUS-FNA for pancreatic tumor; Comparison between needle with side reverse bevel and standard needle
Acronym
Randomized cross-over clinical trial about the diagnostic accuracy of EUS-FNA for pancreatic tumor; Comparison between a needle with side reverse bevel and a standard needle
Scientific Title
Randomized cross-over clinical trial about the diagnostic accuracy of EUS-FNA for pancreatic tumor; Comparison between needle with side reverse bevel and standard needle
Scientific Title:Acronym
Randomized cross-over clinical trial about the diagnostic accuracy of EUS-FNA for pancreatic tumor; Comparison between a needle with side reverse bevel and a standard needle
Region
| Japan |
Condition
Condition
pancreatic tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of diagnostic accuracy between a needle with side reverse bevel and a standard needle
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy
Key secondary outcomes
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
GroupA: Puncture the lesion on the first and the third time with Echo Tip Procore (side reverse beveled) needle , and on the second and the fourth time with Echo Tip Ultra (standard) needle.
Interventions/Control_2
GroupB: Puncture the lesion on the second and the fourth time with Echo Tip Procore (side reverse beveled)needle, and on the first and third with Echo Tip Ultra (standard) 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
1)Cases need histological or cytological diagnosis for treatment
2)Cases obtained written informed consent
Key exclusion criteria
1)Cases with high risk of puncturing cystic lesion
2)Cases with known bleeding disorders
3)Cases regarded by doctors as inappropriate for the enrollment for some reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Kida |
Organization
Kitasato University school of medicine
Division name
Gastroenterolgy
Zip code
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa
TEL
042-778-8111
m-kida@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Iwai |
Organization
Kitasato University School of medicine
Division name
Gastroenterolgy
Zip code
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa
TEL
042-778-8111
Homepage URL
t-iwai@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
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
| 2013 | Year | 12 | Month | 20 | 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
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 19 | Day |
Last modified on
| 2016 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014758
