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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013157
Receipt No. R000015341
Scientific Title Non-invasive diagnostic method for IgG4 related sclerosing cholangitis using immunohistopathology and narrow band imaging
Date of disclosure of the study information 2014/02/15
Last modified on 2014/02/14

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Basic information
Public title Non-invasive diagnostic method for IgG4 related sclerosing cholangitis using immunohistopathology and narrow band imaging
Acronym Diagnosis for IgG4-SC using IgG4, FOXP3 and NBI
Scientific Title Non-invasive diagnostic method for IgG4 related sclerosing cholangitis using immunohistopathology and narrow band imaging
Scientific Title:Acronym Diagnosis for IgG4-SC using IgG4, FOXP3 and NBI
Region
Japan

Condition
Condition IgG4-related screlosing cholangitis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness of biopsy using immunostain of the duodenal papilla and dynamic NBI (D-NBI) and in the different diagnosis for diseases with hilar biliary stricture included IgG4-SC.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assess the efficacy of the non-invasive diagnostic methods such as endoscopic biopsy and NBI.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Endoscopic biopsy using immunohistochimestry using IgG4 and FOXOP3 and NBI.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.IgG4-SC pts who visited to Yokohama City university and/pr Kanto Medical center hospital.
2.Pts having no tendency of bleeding for endoscopic biopsy.
3. Pts who apply to informed conscent.
Key exclusion criteria 1. Pts having tendency for bleeding
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kensuke kubota
Organization Yokohama City University Hospital
Division name Endoscopic unit
Zip code
Address 3-9 Fukuura,Yokohma
TEL 045
Email kubotak@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name saito satoru
Organization Yokohama City Universsity
Division name Gastroeneterology
Zip code
Address 3-9 Fukuura,Yokohama
TEL 045-787-2800
Homepage URL
Email kubotak@yokohma-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization Yokohama City University Hospital
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
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
2014 Year 02 Month 15 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
2009 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 14 Day
Last modified on
2014 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015341

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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