UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012177 |
|---|---|
| Receipt number | R000014236 |
| Scientific Title | Comparison of a standard 19-gauge needle and a new 19-gauge histology needle in diagnostic yields of endoscopic ultrasound-guided fine needle aspiration for solid tumors. Multicenter prospective randomized controlled study |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2016/11/08 19:42:18 |
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Basic information
Public title
Comparison of a standard 19-gauge needle and a new 19-gauge histology needle in diagnostic yields of endoscopic ultrasound-guided fine needle aspiration for solid tumors. Multicenter prospective randomized controlled study
Acronym
19-gauge histology needle vs 19-gauge standard needle in EUS-FNA
Scientific Title
Comparison of a standard 19-gauge needle and a new 19-gauge histology needle in diagnostic yields of endoscopic ultrasound-guided fine needle aspiration for solid tumors. Multicenter prospective randomized controlled study
Scientific Title:Acronym
19-gauge histology needle vs 19-gauge standard needle in EUS-FNA
Region
| Japan |
Condition
Condition
solid tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare diagnostic yields between a standard needle and a new histology needle in EUS-FNA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy in histological analysis
Key secondary outcomes
Yield of visible core
Yield of core specimen on histological analysis
Success rates of FNA
Complication rate of EUS-FNA
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
first pass:A standard 19-gauge FNA
neelde
2nd pass:A new 19-gauge histology FNA needle
Interventions/Control_2
first pass:A new 19-gauge histology FNA needle
2nd pass:A standard 19-gauge FNA
neelde
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) Patients with a solid mass which is measured more than 20mm and located around upper intestine on imaging studies
2)Patients who understand and willing to give a written informed consent
Key exclusion criteria
1) Patients with bleeding tendency or patients who cannot stop taking antiplatelet agents or anticoagulant agents
2) PS of more than 4
3) possible pregnancy
4) Age<20
5) Patients who are judged inappropriate by a assigned physician
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu, Gifu, Japan
TEL
058-230-6308
takuji@w7.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu, Gifu, Japan
TEL
058-230-6308
Homepage URL
takuji@w7.dion.ne.jp
Sponsor or person
Institute
First Dept. of Internal Medicien, Gifu University Hospital
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
岐阜大学医学部附属病院（岐阜県） 岐阜市民病院（岐阜県）、東京大学病院（東京）、東京警察病院（東京）、関東中央病院（東京）
Gifu University Hospital (Gifu), Gifu Municipal Hospital (Gifu), University of Tokyo Hospital (Tokyo), Tokyo Metropolitan Police Hospital(Tokyo), Kanto Central Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 01 | 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 | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 31 | Day |
Last modified on
| 2016 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014236
