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UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000002199
Receipt No. R000002701
Scientific Title Study of diagnostic procedure of acute cellular rejection(ACR) using bile in liver transplantation
Date of disclosure of the study information 2009/07/15
Last modified on 2012/03/28

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Basic information
Public title Study of diagnostic procedure of acute cellular rejection(ACR) using bile in liver transplantation
Acronym Study of diagnostic procedure of acute cellular rejection(ACR) using bile in liver transplantation
Scientific Title Study of diagnostic procedure of acute cellular rejection(ACR) using bile in liver transplantation
Scientific Title:Acronym Study of diagnostic procedure of acute cellular rejection(ACR) using bile in liver transplantation
Region
Japan

Condition
Condition Liver transplant recipients
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish a diagnostic procedure of ACR using bile in liver transplantation
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes identify the bile proteins
Key secondary outcomes correlation between clinical information at acute cellular rejection and bile protein

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 1. Among liver transplant patients, understand the research contents and sign the consent documents

2. After liver transplant operation, patient has bile drainage tube
Key exclusion criteria 1. Do not obtain agreement in the research

2. After liver transplant operation, patient doesn't have bile drainage tube
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Mori
Organization Osaka university graduate school of medicine
Division name Department of gastroenterological surgery
Zip code
Address 2-2 yamadaoka suita city Osaka fu
TEL 06-6879-3251
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Wada
Organization Osaka university graduate school of medicine
Division name Department of gastroenterological surgery
Zip code
Address 2-2 yamadaoka suita city Osaka fu
TEL 06-6879-3251
Homepage URL
Email hwada98@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka university graduate school of medicine
Department of gastroenterological surgery
Institute
Department

Funding Source
Organization None
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
2009 Year 07 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 Suspended
Date of protocol fixation
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Suspended collecting the samples

Management information
Registered date
2009 Year 07 Month 14 Day
Last modified on
2012 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002701

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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