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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028819
Receipt No. R000032963
Scientific Title Prospective exploratory study on the accuracy of brush cytology for biliary stricture using a new wire-guided brush
Date of disclosure of the study information 2017/10/01
Last modified on 2019/08/29

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Basic information
Public title Prospective exploratory study on the accuracy of brush cytology for biliary stricture using a new wire-guided brush
Acronym Prospective exploratory study on the accuracy of brush cytology for biliary stricture using a new wire-guided brush
Scientific Title Prospective exploratory study on the accuracy of brush cytology for biliary stricture using a new wire-guided brush
Scientific Title:Acronym Prospective exploratory study on the accuracy of brush cytology for biliary stricture using a new wire-guided brush
Region
Japan

Condition
Condition cholangiocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 accuracy of brush cytology for biliary stricture using a new wire-guided brush
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes accuracy of brush cytology for biliary stricture using a new wire-guided brush
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 new wire-guided brush
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) Cases suspected biliary stricture due to cancer
2) Cases obtained written informed consent
Key exclusion criteria 1) Cases regarded by doctors as inappropriate for the enrollment for some reasons
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Mitsuhiro
Middle name
Last name Kida
Organization Kitasato University school of medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL +81-42-778-8111
Email m-kida@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Miyata
Organization Kitasato University school of medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL +81-42-778-8111
Homepage URL
Email miyata@kitasato-u.ac.jp

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

Funding Source
Organization MEDICAL SYSTEMS BUSINESS DIV.
FUJIFILM CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization IRB of Kitasato University School of Medicine
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
Tel +81-42-778-8111
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

Other administrative information
Date of disclosure of the study information
2017 Year 10 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 30
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 No longer recruiting
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
2017 Year 11 Month 29 Day
Anticipated trial start date
2017 Year 11 Month 29 Day
Last follow-up date
2020 Year 11 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 25 Day
Last modified on
2019 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032963

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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