UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048659
Receipt number R000055448
Scientific Title Research of serum autotaxin levels for predicting liver fibrosis and posthepatectomy liver failure
Date of disclosure of the study information 2022/08/13
Last modified on 2022/08/12 22:38:57

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Basic information

Public title

Research of serum autotaxin levels for predicting liver fibrosis and posthepatectomy liver failure

Acronym

Research of serum autotaxin levels for predicting liver fibrosis and posthepatectomy liver failure

Scientific Title

Research of serum autotaxin levels for predicting liver fibrosis and posthepatectomy liver failure

Scientific Title:Acronym

Research of serum autotaxin levels for predicting liver fibrosis and posthepatectomy liver failure

Region

Japan


Condition

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationship between serum autotaxin levels and the rate of liver resection and postoperative liver failure.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The predictive power of autotaxin for posthepatectomy liver failure

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

16 years-old <

Age-upper limit

89 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who underwent liver resection and whose preoperative serum was preserved were enrolled.

Key exclusion criteria

Patients deemed unsuitable for participation in this study by the principal investigator were excluded.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Kojiro
Middle name
Last name Taura

Organization

Department of Surgery, Kyoto University Graduate School of Medicine

Division name

Division of Hepato-Biliary-Pancreatic Surgery and Transplantation

Zip code

606-8507

Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan

TEL

0757513111

Email

ktaura@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Kojiro
Middle name
Last name Taura

Organization

Department of Surgery, Kyoto University Graduate School of Medicine

Division name

Division of Hepato-Biliary-Pancreatic Surgery and Transplantation

Zip code

606-8507

Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan

TEL

0757513111

Homepage URL


Email

ktaura@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Surgery, Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

TOSOH Bioscience

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of the Kyoto University Graduate School and Faculty of Medicine

Address

Konoe-cho, Yoshida, Sakyo Ward, 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

2022 Year 08 Month 13 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

269

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

Completed

Date of protocol fixation

2018 Year 11 Month 27 Day

Date of IRB

2020 Year 03 Month 30 Day

Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective study


Management information

Registered date

2022 Year 08 Month 12 Day

Last modified on

2022 Year 08 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055448


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name