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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041270
Receipt No. R000046374
Scientific Title Diagnostic accuracy of subepithelial lesions by EUS-guided fine-needle biopsy using cut-off value of the stereomicroscopically visible white core, multi-center prospective trial
Date of disclosure of the study information 2020/08/01
Last modified on 2020/08/01

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Basic information
Public title Diagnostic accuracy of subepithelial lesions by EUS-guided fine-needle biopsy using cut-off value of the stereomicroscopically visible white core, multi-center prospective trial
Acronym Diagnostic accuracy of subepithelial lesions by EUS-FNB using cut-off value of the SVWC, multi-center prospective trial
Scientific Title Diagnostic accuracy of subepithelial lesions by EUS-guided fine-needle biopsy using cut-off value of the stereomicroscopically visible white core, multi-center prospective trial
Scientific Title:Acronym Diagnostic accuracy of subepithelial lesions by EUS-FNB using cut-off value of the SVWC, multi-center prospective trial
Region
Japan

Condition
Condition upper gastrointestinal subepithelial lesion
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the diagnostic accuracy of upper gastrointestinal subepithelial lesions derived from proper muscle layer by EUS-guided fine-needle biopsy using cut-off value of the stereomicroscopically visible white core.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sensitivity
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
Maneuver
Interventions/Control_1 procedure of the EUS-guided fine-needle biopsy with 22-gauge needle using cut-off value of the stereomicroscopically visible white core
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. upper gastrointestinal subepithelial lesions derived from proper muscle layer which are required EUS-FNB for pathological diagnosis
2. providing written informed consent, and age =or >20
Key exclusion criteria 1. bleeding disorders
2. severe mental disorders
3. patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Kosuke
Middle name
Last name Okuwaki
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
TEL 81-42-778-8111
Email kokuwaki@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Okuwaki
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
TEL 81-42-778-8111
Homepage URL
Email kokuwaki@kitasato-u.ac.jp

Sponsor
Institute Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization self funding
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 Ethics Committee of Kitasato University
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa, 252-0374 Japan
Tel 81-42-778-7756
Email rinri@med.kitasato-u.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 Kitasato University Hospital
JCHO Sagamino Hospital
Kitasato University Medical Center
Isehara Hospital

Other administrative information
Date of disclosure of the study information
2020 Year 08 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 Open public recruiting
Date of protocol fixation
2020 Year 06 Month 01 Day
Date of IRB
2020 Year 07 Month 31 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 31 Day
Last modified on
2020 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046374

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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