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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033348
Receipt No. R000037173
Official scientific title of the study Living-donor liver transplantation for unresectable perihilar cholangiocarcinoma
Date of disclosure of the study information 2018/07/10
Last modified on 2018/07/10

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Basic information
Official scientific title of the study Living-donor liver transplantation for unresectable perihilar cholangiocarcinoma
Title of the study (Brief title) liver transplantation for perihilar cholangiocarcinoma
Region
Japan

Condition
Condition perihilar cholangiocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate safety and efficacy of living-donor liver transplantation for unresectable perihilar cholangiocarcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5-year overall survival rate and in-hospital mortality
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 living-donor liver transplantation
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
70 years-old >=
Gender Male and Female
Key inclusion criteria perihilar cholangiocarcinoma that is deemed unresectable due to any of the following reasons ; a) function of the liver remnant is insufficient b) reconstruction of the vascular structure for the liver remnant is impossible or extremely difficult c) the tumor extends beyond the resection limit d) impossible to locate the tumor associated with primary sclerosing cholangitis
Key exclusion criteria a) the tumor extends beyond the upper border of the pancreas
b) distant metastasis (including liver metastasis)
c) radiologically or clinically obvious lymph node metastasis
Target sample size 10

Research contact person
Name of lead principal investigator Shinji Uemoto
Organization Kyoto University
Division name Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL 075-751-3242
Email uemoto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person Kojiro Taura
Organization Kyoto University
Division name Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL 075-751-3242
Homepage URL
Email ktaura@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Kyoto University
Organization
Division
Category of Funding Organization Other
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
2018 Year 07 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 10 Day
Anticipated trial start date
2018 Year 07 Month 10 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

Management information
Registered date
2018 Year 07 Month 10 Day
Last modified on
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037173

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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