UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014845 |
|---|---|
| Receipt number | R000017147 |
| Scientific Title | Effects of perioperative nutritional intervention on liver regeneration after hepatectomy. |
| Date of disclosure of the study information | 2014/08/13 |
| Last modified on | 2017/09/04 11:04:47 |
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Basic information
Public title
Effects of perioperative nutritional intervention on liver regeneration after hepatectomy.
Acronym
Effects of perioperative nutritional intervention on liver regeneration after hepatectomy.
Scientific Title
Effects of perioperative nutritional intervention on liver regeneration after hepatectomy.
Scientific Title:Acronym
Effects of perioperative nutritional intervention on liver regeneration after hepatectomy.
Region
| Japan |
Condition
Condition
hepatocellular carcinoma cases require hepatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of perioperative nutritional intervention for hepatocellular carcinoma with hypoalbuminemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
postoperative improvement of liver function
Key secondary outcomes
postoperative course
liver regeneration rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Branched-chain amino acid granules(BCAA, Livact) is orally administered three times a day for 2 weeks prior to hepatectomy and 1 month after hepatectomy(hypoalbuminemia group).
Interventions/Control_2
No administration of BCAA (hypoalbuminemia group).
Interventions/Control_3
No administration of BCAA (normal albumin level group).
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
1)hepatocellular carcinoma(including combined hepatocellular and cholangiocarcinoma) by preoperative imaging examination
2)planned hepatectomy
3)ECOG Performance Status 0 to 2
4)appropriate liver function for hepatectomy according to the results of the Child-Pugh classification and the ICG-R15 test (within 30 days before the registration)
5)written informed consent
Key exclusion criteria
1)severe diabetes, or suspected abnormal sugar metabolism because of high dosage of steroids
2)abnormal amino acid metabolism
3)history of hypersensitivity against Livact
4)pregnant or willing to get pregnant
5)patien's offer discontinuation of the study
6)doctor's decision not to be registered to the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Itano |
Organization
Department of Surgery, Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-3353-1211
contact@keio-hpbts.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yagi |
Organization
Department of surgery, Keio University, school of medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
contact@keio-hpbts.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
慶応義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 03 | 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 | 08 | Month | 12 | Day |
Last modified on
| 2017 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017147
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
