UMIN-CTR Clinical Trial

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
Institute	Department of Surgery, Kyoto University Graduate School of Medicine
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055448