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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030643
Receipt No. R000034860
Scientific Title Usefulness of endoscopic-ultrasound guided fine needle biopsy for diagnosis of subepithelial tumors
Date of disclosure of the study information 2017/12/30
Last modified on 2019/01/05

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Basic information
Public title Usefulness of endoscopic-ultrasound guided fine needle biopsy for diagnosis of subepithelial tumors
Acronym Usefulness of EUS-FNB for subepithelial tumors
Scientific Title Usefulness of endoscopic-ultrasound guided fine needle biopsy for diagnosis of subepithelial tumors
Scientific Title:Acronym Usefulness of EUS-FNB for subepithelial tumors
Region
Japan

Condition
Condition Subepithelial tumors
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of FNB needle for diagnosis of subepithelial tumors compared to that with FNA needle.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Definitively diagnosis rate
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients underwent EUS-guided sampling for subepithelial tumors
Key exclusion criteria 1)Patients with <15mm size of subepithelial tumor
2)Patients with subepithelial tumor-like cancer
3)A follow-up period of <12 months in patients whithout surgery
4)Patients who refused to participate
5)Patients considered ineligible by attending physicians
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadahisa Inoue
Organization Aichi Medical University
Division name Department of Gastroenterology
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561-62-3311
Email tinoue-tag@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadahisa Inoue
Organization Aichi Medical University
Division name Department of Gastroenterology
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561-62-3311
Homepage URL
Email tinoue-tag@umin.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 12 Month 30 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
2017 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 01 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 Retrospective dual-center study

Management information
Registered date
2017 Year 12 Month 30 Day
Last modified on
2019 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034860

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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