UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033348 |
|---|---|
| Receipt number | R000037173 |
| Scientific Title | Living-donor liver transplantation for unresectable perihilar cholangiocarcinoma |
| Date of disclosure of the study information | 2018/07/10 |
| Last modified on | 2022/03/31 12:54:43 |
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Basic information
Public title
Living-donor liver transplantation for unresectable perihilar cholangiocarcinoma
Acronym
liver transplantation for perihilar cholangiocarcinoma
Scientific Title
Living-donor liver transplantation for unresectable perihilar cholangiocarcinoma
Scientific Title:Acronym
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
| 1st name | Etsuro |
| Middle name | |
| Last name | Hatano |
Organization
Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL
075-751-3651
etsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Fukumitsu |
Organization
Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL
075-751-3242
Homepage URL
tsurugi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto-city
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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 |
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 10 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037173
