UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004770 |
|---|---|
| Receipt number | 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 13:57:56 |
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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
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
taiji@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005639
