UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011774 |
|---|---|
| Receipt number | R000013763 |
| Scientific Title | A study on usefulness of endoscopic ultrasonography elastography and endoscopic ultrasonography guided fine needle aspiration in gastric submucosal tumor |
| Date of disclosure of the study information | 2013/09/16 |
| Last modified on | 2016/03/17 21:18:25 |
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Basic information
Public title
A study on usefulness of endoscopic ultrasonography elastography and endoscopic ultrasonography guided fine needle aspiration in gastric submucosal tumor
Acronym
A study on usefulness of endoscopic ultrasonography elastography and endoscopic ultrasonography guided fine needle aspiration in gastric submucosal tumor
Scientific Title
A study on usefulness of endoscopic ultrasonography elastography and endoscopic ultrasonography guided fine needle aspiration in gastric submucosal tumor
Scientific Title:Acronym
A study on usefulness of endoscopic ultrasonography elastography and endoscopic ultrasonography guided fine needle aspiration in gastric submucosal tumor
Region
| Japan |
Condition
Condition
Gastric submucosal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefulness of endoscopic ultrasonography elastography in qualitative diagnosis of gastric submucosal tumor comparing with endoscopic ultrasonography guided fine needle aspiration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the organization elasticity, sensitivity, specificity, the diagnostic accuracy of EUS elastography
Key secondary outcomes
To evaluate frequency of complications and to compare ultrasound elastography
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Gastric submucosal tumors more than 2cm are observed with EUS elastography before EUS-FNA.
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
The patiants who have gastric submucosal tumor more than 2cm.
Cases with written and oral informed consent are included
Key exclusion criteria
Cases endoscopic approach is difficult
Cases of Performance status 4
Cases with severe complications are excluded
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Tsuji |
Organization
Tokyo Medical University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
6-7-1, Nishishinjuku, Shinjuku-Ku, Tokyo, Japan
TEL
03-3342-6111
specialweek1968@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Tsuji |
Organization
Tokyo Medical University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
6-7-1, Nishishinjuku, Shinjuku-Ku, Tokyo, Japan
TEL
03-3342-6111
Homepage URL
specialweek1968@yahoo.co.jp
Sponsor or person
Institute
Tokyo Medical 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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 16 | 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 | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 16 | 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
| 2013 | Year | 09 | Month | 15 | Day |
Last modified on
| 2016 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013763
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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