UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Reserch of liver failure biomaker after a hepatectomy
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Ryusei Matsuyama
Organization	Yokohama city university
Division name	Depertment of gastroenterologicl surgery
Address	3-13, Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2650
Email	ryusei@terra.dti.ne.jp

Public contact
Name of contact person	Yusuke Suwa
Organization	Yokohama city university
Division name	Depertment of gastroenterologicl surgery
Address	3-13, Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2650
Homepage URL
Email	yusuke_232002@yahoo.co.jp

Sponsor
Institute	Yokohama city university Depertment of gastroenterologicl surgery
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 10 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018199