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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021410
Receipt No. R000024563
Scientific Title A multicenter randomized controlled study evaluating 20G needl with a core trap for EUS guided fine needle biopsy in diagnosis of gastric submucosal tumor
Date of disclosure of the study information 2016/04/01
Last modified on 2020/09/11

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Basic information
Public title A multicenter randomized controlled study evaluating 20G needl with a core trap for EUS guided fine needle biopsy in diagnosis of gastric submucosal tumor
Acronym The utility of 20G needl with a core trap for EUS guided fine needle biopsy in diagnosis of gastric submucosal tumor
Scientific Title A multicenter randomized controlled study evaluating 20G needl with a core trap for EUS guided fine needle biopsy in diagnosis of gastric submucosal tumor
Scientific Title:Acronym The utility of 20G needl with a core trap for EUS guided fine needle biopsy in diagnosis of gastric submucosal tumor
Region
Japan

Condition
Condition Gastoric submucosal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In diagnoses of gastric submucosal tumors by EUS-FNA, 20G needle with a core trap is evaluated in terms of efficacy and safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of satisfactory sampling for histological diagnosis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 EUS-FNA needle with a core trap
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 1. Gastoric submucosal tumors more than 10 mm
2. ECOG performance status = 1, 2
3. No severe dysfunction in other organs
4. Requirement of EUS-FNA for deciding surgical resection
5. Written informed consent obtained from patients
Key exclusion criteria 1. Presence of intervening vessels or other organs on the puncture line
2. High risk of complications (bleeding, tumor seeding)
3. Inability to obtain informed consent
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Ken
Middle name
Last name Kamata
Organization Kinki University Faculty Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 589-8511
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL 072-366-0221
Email m-kitano@med.kindai.ac.jp

Public contact
Name of contact person
1st name Ken
Middle name
Last name Kamata
Organization Kinki University Faculty Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 589-8511
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL 072-366-0221
Homepage URL
Email ky11@leto.eonet.ne.jp

Sponsor
Institute Osaka EUS-FNA Study Group
Institute
Department

Funding Source
Organization Kinki University Faculty 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 Institutional Review Board of of Kindai University Faculty of Medicine
Address 377-2,Ohno-Higashi,Osaka,Jpan
Tel 0723660221
Email zizen@med.kindai.ac.jp

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
2016 Year 04 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 Enrolling by invitation
Date of protocol fixation
2016 Year 02 Month 09 Day
Date of IRB
2016 Year 04 Month 28 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2020 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 09 Day
Last modified on
2020 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024563

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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