UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008447 |
|---|---|
| Receipt number | R000009935 |
| Scientific Title | Randomized comparison test of aspiration needles to gastric submucosal tumors about availability and safety of Endoscopic ultrasonography guided fine needle aspiration(EUS-FNA) |
| Date of disclosure of the study information | 2012/07/17 |
| Last modified on | 2013/12/10 20:23:44 |
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Basic information
Public title
Randomized comparison test of aspiration needles to gastric submucosal tumors about availability and safety of Endoscopic ultrasonography guided fine needle aspiration(EUS-FNA)
Acronym
Comparison test of EUS-FNA needles to gastric submucosal tumors
Scientific Title
Randomized comparison test of aspiration needles to gastric submucosal tumors about availability and safety of Endoscopic ultrasonography guided fine needle aspiration(EUS-FNA)
Scientific Title:Acronym
Comparison test of EUS-FNA needles to gastric submucosal tumors
Region
| Japan |
Condition
Condition
gastric submucosal tumors
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to estimate two EUS-FNA needles about diagnostic efficacy and safety for the gastric submucosal tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity, accuracy and incidence of complication
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Randomized 10 cases are performed EUS-FNA with normal 22G needle.
Interventions/Control_2
Randomized 10 cases are performed EUS-FNA with 22G needle with side port.
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 patients with gastric submucosal tumors and with indication of EUS-FNA
Key exclusion criteria
(1) Patients with bleeding tendency
(2) Patients under anticoaglant therapy
(3) Plt< 30000
(4) Tumor size < 2cm
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Watanabe Seitaro |
Organization
Yokohama City University Hospital
Division name
Gstroenterology Division
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Watanabe Seitaro |
Organization
Yokohama City University Hospital
Division name
Gastroenterology Division
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
Homepage URL
Sponsor or person
Institute
Yokohama City University, Gastroenterology Division
Institute
Department
Personal name
Funding Source
Organization
no
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
| 2012 | Year | 07 | Month | 17 | 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
| 2012 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 17 | 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
| 2012 | Year | 07 | Month | 16 | Day |
Last modified on
| 2013 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009935
