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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name