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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004770
Receipt No. R000005639
Scientific Title The protective effects of neutrophil elastase inhibitor on organ dysfunction after hepatectomy
Date of disclosure of the study information 2011/01/01
Last modified on 2010/12/16

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Basic information
Public title The protective effects of neutrophil elastase inhibitor on organ dysfunction after hepatectomy
Acronym neutrophil elastase inhibitor and hepatectomy
Scientific Title The protective effects of neutrophil elastase inhibitor on organ dysfunction after hepatectomy
Scientific Title:Acronym neutrophil elastase inhibitor and hepatectomy
Region
Japan

Condition
Condition hepatocellular carcinoma, metastatic liver cancer, cholangiocarcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 study of efficacy of neutrophil elastase inhibitor on organ dysfunction after hepatectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes improvement of liver dysfunction after hepatectomy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 group of administration of neutrophil elastase inhibitor
Interventions/Control_2 non-administration group
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
85 years-old >=
Gender Male and Female
Key inclusion criteria patients with liver tumor who takes hepatectomy
Key exclusion criteria onset of adverse effects of drug
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasutsugu Takada
Organization Ehime University
Division name Hepato-biliary-pancreatic surgery and Transplantation
Zip code
Address Shitsukawa, Touon-city, Ehime, Japan
TEL 089-964-7665
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Ehime University
Division name Hepato-biliary-pancreatic surgery and Transplantation
Zip code
Address
TEL
Homepage URL
Email taiji@m.ehime-u.ac.jp

Sponsor
Institute Ehime University
Institute
Department

Funding Source
Organization Division of Hepato biliary pancreatic surgery and Transplantation, Ehime University
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
Email

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 愛媛大学病院

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 01 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
2010 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 21 Day
Last modified on
2010 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005639

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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