UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013766 |
|---|---|
| Receipt number | R000016067 |
| Scientific Title | Consideration of appropriate procedure in the endoscopic ultrasound fine needle aspiration for small smaller than 10mm |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2016/05/22 16:42:29 |
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Basic information
Public title
Consideration of appropriate procedure in the endoscopic ultrasound fine needle aspiration for small smaller than 10mm
Acronym
Consideration of appropriate procedure in the endoscopic ultrasound fine needle aspiration for small smaller than 10mm
Scientific Title
Consideration of appropriate procedure in the endoscopic ultrasound fine needle aspiration for small smaller than 10mm
Scientific Title:Acronym
Consideration of appropriate procedure in the endoscopic ultrasound fine needle aspiration for small smaller than 10mm
Region
| Japan |
Condition
Condition
small tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In order to examine the appropriate procedure of EUS-FNA for the tumor smaller than 10mm
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Specimen collection rate and Correct diagnostic rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
We perform the EUS-FNA by Conventional metod.
Interventions/Control_2
We perform the EUS-FNA by Woodpecker method.
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
The Pacient who has the tumor smaller than 10mm
Key exclusion criteria
1)Performance Status (PS)4.
2)The patient who has serious disease.
3)The pacient with anticoagulant therapy.
4)The woman becomes pregnant or might be pregnant.
5)Approach with the endoscope is difficult.
6)Diagnosis has been determined already.
7)Visualization of the tumor by the EUS is impossible.
8)Insertion of the endoscope is impossible.
9)Reduction of platelet (less than 50,000mm3)
10)PT-INR greater than 1.5
11)The patient was judged the physician to be inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Irisawa |
Organization
Fukushima Medical University Aizu Medical Center
Division name
Depattment of Gastroenterology
Zip code
Address
21-2 Maeda,Tanisawa,Kawahigashi,Aizuwakamatsu City,FUkushima,JAPAN
TEL
0242-75-2100
k.hoshi.529@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koki Hoshi |
Organization
Fukushima Medical University Aizu Medical Center
Division name
Depattment of Gastroenterology
Zip code
Address
21-2 Maeda,Tanisawa,Kawahigashi,Aizuwakamatsu City,FUkushima,JAPAN
TEL
0242-75-2100
Homepage URL
k.hoshi.529@gmail.com
Sponsor or person
Institute
Fukushima Medical University Aizu Medical Center Depattment of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University Aizu Medical Center Depattment of Gastroenterology
Organization
Division
Category of Funding Organization
Local Government
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
| 2014 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 20 | Day |
Last modified on
| 2016 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016067
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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