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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name