UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010021 |
|---|---|
| Receipt number | R000011518 |
| Scientific Title | A multicenter randomized controlled study comparing needles with and without side hole for EUS guided fine needle biopsy in diagnosis of pancreatic solid lesions. |
| Date of disclosure of the study information | 2013/02/18 |
| Last modified on | 2017/02/10 17:41:13 |
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Basic information
Public title
A multicenter randomized controlled study comparing needles with and without side hole for EUS guided fine needle biopsy in diagnosis of pancreatic solid lesions.
Acronym
A study comparing diagnositic yields between EUS-FNA needles with and without side hole.
Scientific Title
A multicenter randomized controlled study comparing needles with and without side hole for EUS guided fine needle biopsy in diagnosis of pancreatic solid lesions.
Scientific Title:Acronym
A study comparing diagnositic yields between EUS-FNA needles with and without side hole.
Region
| Japan |
Condition
Condition
Pancreatic tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In diagnoses of pancreatic solid lesions by EUS-FNA, needles without and with side holes are compared in terms of efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoints: Rate of satisfactory sampling for histological diagnosis, diagnositic accuracy.
Secondary endpoints: rate of adverse events, technical success rate
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
EUS-FNA needle with side hole
Interventions/Control_2
EUS-FNA needle without side hole
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 solid lesions depicted by imaging modalities
ECOG performance status = 1, 2
No severe dysfunction in other organs Requirement of pathological diagnosis for patient treatment
Written informed consent obtained from patients
Key exclusion criteria
Presence of intervening vessels or other organs on the puncture line
High riks of complications (bleeding, tumor seeding)
Inability to obtain informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Kitano |
Organization
Kinki University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL
072-366-0221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Kamata |
Organization
Kinki University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL
072-366-0221
Homepage URL
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
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 | 02 | Month | 18 | 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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 12 | Day |
Last modified on
| 2017 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011518
