UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of clinical course after liver transplantation for primary sclerosing cholangitis
Title of the study (Brief title)	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	Yoshihide Ueda
Organization	Kyoto University
Division name	Gastroenterology and Hepatology
Address	54 Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL	075-751-4319
Email	yueda@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Yoshihide Ueda
Organization	Kyoto University
Division name	Gastroenterology and Hepatology
Address	54 Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL	075-751-4319
Homepage URL
Email	yueda@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Gastroenterology and Hepatology, Kyoto University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029151