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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007827
Receipt No. R000009226
Scientific Title Japanese Biliary Atresia Registry
Date of disclosure of the study information 2012/07/01
Last modified on 2017/02/11

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Basic information
Public title Japanese Biliary Atresia Registry
Acronym Japanese Biliary Atresia Registry
Scientific Title Japanese Biliary Atresia Registry
Scientific Title:Acronym Japanese Biliary Atresia Registry
Region
Japan

Condition
Condition biliary atresia
Classification by specialty
Hepato-biliary-pancreatic surgery Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 national survey for biliary atresia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes survival, jaundice disappeared, liver transplantation
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria biliary atreisa
Key exclusion criteria non
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Nio
Organization Tohoku University
Division name Graduate School of Medicine
Zip code
Address Seiryo-machi 1-1, Aoba-ku, Sendai, Japan
TEL 022-717-7237
Email mnio@ped-surg.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Sasaki
Organization Japanese Biliary Atresia Society
Division name office
Zip code
Address Seiryo-machi 1-1, Aoba-ku, Sendai, Japan
TEL 022-717-7237
Homepage URL
Email h-sasaki@ped-surg.med.tohoku.ac.jp

Sponsor
Institute Japanese Biliary Atresia Society
Institute
Department

Funding Source
Organization Japanese Biliary Atresia Society
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
2012 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially 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 Enrolling by invitation
Date of protocol fixation
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 07 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 The number of annual occurence of biliary atresia is grasped, and the first time treatment results of each case are grasped.
Furthermore, pursuit registration of the case concerned is carried out, and a long-term prognosis is grasped.

Management information
Registered date
2012 Year 04 Month 24 Day
Last modified on
2017 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009226

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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