UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041155
Receipt number R000047002
Scientific Title Short-term and long-term outcomes in living donors for liver transplantation
Date of disclosure of the study information 2020/07/19
Last modified on 2021/07/20 22:20:22

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Basic information

Public title

Short-term and long-term outcomes in living donors for liver transplantation

Acronym

Short-term and long-term outcomes in living donors for liver transplantation

Scientific Title

Short-term and long-term outcomes in living donors for liver transplantation

Scientific Title:Acronym

Short-term and long-term outcomes in living donors for liver transplantation

Region

Japan


Condition

Condition

living donors for liver transplantation

Classification by specialty

Surgery in general Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to investigate short-term and long-term outcomes following donor hepatectomy

Basic objectives2

Others

Basic objectives -Others

na

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

short-term and long-term outcomes following donor hepatectomy

Key secondary outcomes

short-term outcomes according to the era and the graft type


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

living donors who underwent DH between 1996 and 2019

Key exclusion criteria

NONE

Target sample size

408


Research contact person

Name of lead principal investigator

1st name Kosei
Middle name
Last name Takagi

Organization

Okayama University Hospital

Division name

Department of Gastroenterological Surgery

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama

TEL

+81-86-223-7151

Email

kotakagi15@gmail.com


Public contact

Name of contact person

1st name Kosei
Middle name
Last name Takagi

Organization

Okayama University Hospital

Division name

Department of Gastroenterological Surgery

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama

TEL

+81-86-223-7151

Homepage URL


Email

kotakagi15@gmail.com


Sponsor or person

Institute

Okayama University Hospital

Institute

Department

Personal name



Funding Source

Organization

na

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

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee

Address

2-5-1 Shikata-cho, Kita-ku, Okayama

Tel

086-235-6938

Email

mae6605@adm.okayama-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

2006-011

Org. issuing International ID_1

2006-011

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 07 Month 19 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

408

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

Main results already published

Date of protocol fixation

2020 Year 06 Month 05 Day

Date of IRB

2020 Year 06 Month 05 Day

Anticipated trial start date

2020 Year 06 Month 05 Day

Last follow-up date

2020 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

N/A


Management information

Registered date

2020 Year 07 Month 19 Day

Last modified on

2021 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047002


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name