UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025336 |
|---|---|
| Receipt number | R000029151 |
| Scientific Title | Analysis of clinical course after liver transplantation for primary sclerosing cholangitis |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2016/12/20 16:56:36 |
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Basic information
Public title
Analysis of clinical course after liver transplantation for primary sclerosing cholangitis
Acronym
Primary sclerosing cholangitis after liver transplantation
Scientific Title
Analysis of clinical course after liver transplantation for primary sclerosing cholangitis
Scientific Title:Acronym
Primary sclerosing cholangitis after liver transplantation
Region
| Japan |
Condition
Condition
Primary sclerosing cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical course after liver transplantation for primary sclerosing cholangitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence of primary sclerosing cholangitis
Key secondary outcomes
Patient survival, graft survival, risk factors for recurrence of primary sclerosing cholangitis, risk factors for graft failure
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
Patients who underwent liver transplantation for primary sclerosing cholangitis at Kyoto University Hospital until June 2015.
Key exclusion criteria
Patients who rejected.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihide Ueda |
Organization
Kyoto University
Division name
Gastroenterology and Hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL
075-751-4319
yueda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihide Ueda |
Organization
Kyoto University
Division name
Gastroenterology and Hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL
075-751-4319
Homepage URL
yueda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Gastroenterology and Hepatology, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Gastroenterology and Hepatology, Kyoto University
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
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 | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | 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
Analysis of clinical course; results of blood examination, bacterial culture, pathology of live biopsy, imaging study; treatment, prognosis, etc until October 2016.Statistical analysis of patient and graft survival, recurrence of primary sclerosing cholangitis, risk factors for recurrence and graft failure.
Management information
Registered date
| 2016 | Year | 12 | Month | 20 | Day |
Last modified on
| 2016 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029151
