UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017192 |
|---|---|
| Receipt number | R000019946 |
| Scientific Title | Is the sealing device useful for reducing ascites after hepatectomy with cirrhotic patients? |
| Date of disclosure of the study information | 2015/04/21 |
| Last modified on | 2015/04/20 17:46:03 |
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Basic information
Public title
Is the sealing device useful for reducing ascites after hepatectomy with cirrhotic patients?
Acronym
Is the sealing device useful for reducing ascites after hepatectomy with cirrhotic patients?
Scientific Title
Is the sealing device useful for reducing ascites after hepatectomy with cirrhotic patients?
Scientific Title:Acronym
Is the sealing device useful for reducing ascites after hepatectomy with cirrhotic patients?
Region
| Japan |
Condition
Condition
Primary liver cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of lymphatic sealing device in reducing ascites afer hepatectomy in cirrhotic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between use of the sealing device and the volume of ascites
Key secondary outcomes
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All cases of hepatectomy with cirrhotic liver.
Key exclusion criteria
none
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kitamura |
Organization
National Hospital Organization, Matsumoto Medical Center
Division name
Surgery
Zip code
Address
2-20-30, Muraimachiminami, Matsumoto, Nagano
TEL
0263-58-4567
kitamurh@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kitamura |
Organization
National Hospital Organization, Matsumoto Medical Center
Division name
Surgery
Zip code
Address
2-20-30, Muraimachiminami, Matsumoto, Nagano
TEL
0263-58-4567
Homepage URL
kitamurh@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization, Matsumoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | 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
Suitable case records are blindly sampled for statatistical analysis.
Management information
Registered date
| 2015 | Year | 04 | Month | 20 | Day |
Last modified on
| 2015 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019946
