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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042138
Receipt No. R000048022
Scientific Title Prospective exploratory study of efficacy of cell block method with bile cytology using a novel wire-guided brush
Date of disclosure of the study information 2020/11/01
Last modified on 2021/04/20

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Basic information
Public title Prospective exploratory study of efficacy of cell block method with bile cytology using a novel wire-guided brush
Acronym Efficacy of cell block method with bile cytology using a novel brush
Scientific Title Prospective exploratory study of efficacy of cell block method with bile cytology using a novel wire-guided brush
Scientific Title:Acronym Efficacy of cell block method with bile cytology using a novel brush
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the diagnostic accuracy of cell block method with bile cytology using a novel wire-guided brush in patient with biliary stricture
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accuracy of cell block method with bile cytology using a novel wire-guided brush
Key secondary outcomes Adequacy of specimens
Accuracy of bile duct biopsy
Accuracy of bile cytology without cell block method
Complications

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 cell block method with bile cytology using a novel 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. patients with biliary stricture
2. providing written informed consent, and
age =or >20
Key exclusion criteria 1. severe mental disorders
2. patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size 30

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 252-0374 Japan
TEL +81-42-778-8111
Email kokuwaki@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Masayoshi
Middle name
Last name Tadehara
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 tadehara@kitasato-u.ac.jp

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

Funding Source
Organization None
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 IInstitutional Ethics Committee of Kitasato University
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
2020 Year 11 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 10 Month 20 Day
Date of IRB
2020 Year 11 Month 13 Day
Anticipated trial start date
2020 Year 11 Month 20 Day
Last follow-up date
2024 Year 04 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 10 Month 16 Day
Last modified on
2021 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048022

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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