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
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
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
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
