UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015655 |
|---|---|
| Receipt number | R000018199 |
| Scientific Title | Reserch of liver failure biomaker after a hepatectomy |
| Date of disclosure of the study information | 2014/11/11 |
| Last modified on | 2016/05/11 00:57:19 |
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Basic information
Public title
Reserch of liver failure biomaker after a hepatectomy
Acronym
Reserch of liver failure biomaker after a hepatectomy
Scientific Title
Reserch of liver failure biomaker after a hepatectomy
Scientific Title:Acronym
Reserch of liver failure biomaker after a hepatectomy
Region
| Japan |
Condition
Condition
the patient accepting a major hepatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Serch for liver failure biomaeker after mojor hepatectomy.
Basic objectives2
Others
Basic objectives -Others
Reserch of the relations between some cytokine, vWF, and ADAMTS13 and liver failure after major hepatectomy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The rate of liver failure after a mojor hepatectomy.
Key secondary outcomes
mortality rate, complication rate, hospitalization days
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
von Willebrand factor
ADAMTS13
MCP-1
Procalcitonin
Endotoxin Activity Assay
HMGB-1
Interleukin-1beta,4,6,10
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
a patient accepting major hepatectomy
Key exclusion criteria
patient of disagreement
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryusei Matsuyama |
Organization
Yokohama city university
Division name
Depertment of gastroenterologicl surgery
Zip code
Address
3-13, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2650
ryusei@terra.dti.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Suwa |
Organization
Yokohama city university
Division name
Depertment of gastroenterologicl surgery
Zip code
Address
3-13, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2650
Homepage URL
yusuke_232002@yahoo.co.jp
Sponsor or person
Institute
Yokohama city university
Depertment of gastroenterologicl surgery
Institute
Department
Personal name
Funding Source
Organization
Yokohama city university
Depertment of gastroenterologicl surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
横浜市立大学附属病院（神奈川県）、
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 11 | 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
| 2013 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 10 | Day |
Last modified on
| 2016 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018199
