UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021409 |
|---|---|
| Receipt number | R000024562 |
| Scientific Title | A multicenter randomized controlled study evaluating 25G needle with a core trap for EUS guided fine needle biopsy in diagnosis of malignancy of pancreatic neuroendocrine tumors |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2022/03/14 09:39:22 |
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Basic information
Public title
A multicenter randomized controlled study evaluating 25G needle with a core trap for EUS guided fine needle biopsy in diagnosis of malignancy of pancreatic neuroendocrine tumors
Acronym
Evaluating 25G needle with a core trap for EUS guided fine needle biopsy in diagnosis of malignancy of pancreatic neuroendocrine tumors
Scientific Title
A multicenter randomized controlled study evaluating 25G needle with a core trap for EUS guided fine needle biopsy in diagnosis of malignancy of pancreatic neuroendocrine tumors
Scientific Title:Acronym
Evaluating 25G needle with a core trap for EUS guided fine needle biopsy in diagnosis of malignancy of pancreatic neuroendocrine tumors
Region
| Japan |
Condition
Condition
Pancreatic neuroendocrine tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In diagnosis of malignancy of pancreatic neuroendocrine tumors by EUS-FNA, the utility of 25G needle with a core trap are evaluated considering the results of surgical findings as a gold standard
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rates of pancreatic neuroendocrine tumor grading by EUS-FNA with grade of the resected tumor, measuring the Ki-67 index in EUS-FNA specimens
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
25G EUS-FNA needle with a core trap
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 neuroendocrine tumor diagnosed by imaging modalities
2. Requirement of EUS-FNA for deciding surgical resection
3. ECOG performance status = 1, 2
4. No severe dysfunction in other organs
5. Written informed consent obtained from patients
Key exclusion criteria
1. Presence of intervening vessels or other organs on the puncture line
2. High risk of complications (bleeding, tumor seeding)
3. Inability to obtain informed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Kinki University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL
072-366-0221
m-kitano@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Kamata |
Organization
Kinki University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL
072-366-0221
Homepage URL
ky11@leto.eonet.ne.jp
Sponsor or person
Institute
Osaka EUS-FNA Study Group
Institute
Department
Personal name
Funding Source
Organization
Kinki University Faculty of Medicine
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
kindai univercity faculty of medicine
Address
Ohnohigashi 377-2, Osaka-sayamasi, Osaka
Tel
0723660221
zizen@med.kindai.ac.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
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
52
Results
The usefulness of a 25G needle with a side hole for the grading of pancreatic endocrine tumors is demonstrated.
Results date posted
| 2022 | Year | 03 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
PanNEN
Participant flow
Consecutive
Adverse events
Non
Outcome measures
Diagnostic accuracy for the grading of pancreatic endocrine tumors.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | 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
| 2016 | Year | 03 | Month | 09 | Day |
Last modified on
| 2022 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024562
