UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006753 |
|---|---|
| Receipt number | R000007987 |
| Scientific Title | Randomized controlled trial to examine efficacy of late evening snack for the patients undergoing local treatment of hepatocellular carcinoma. |
| Date of disclosure of the study information | 2011/11/21 |
| Last modified on | 2011/11/21 16:33:31 |
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Basic information
Public title
Randomized controlled trial to examine efficacy of late evening snack for the patients undergoing local treatment of hepatocellular carcinoma.
Acronym
Randomized controlled trial to examine efficacy of late evening snack for the patients undergoing local treatment of hepatocellular carcinoma.
Scientific Title
Randomized controlled trial to examine efficacy of late evening snack for the patients undergoing local treatment of hepatocellular carcinoma.
Scientific Title:Acronym
Randomized controlled trial to examine efficacy of late evening snack for the patients undergoing local treatment of hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of branched chain amino acid as late evening snack among patients undergoing radiofrequency ablation for hepatocellular carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of nutrition condition using Masstrichit Index(MI) and COUNT
Key secondary outcomes
Onset rate of life-threatening event (liver failure, esophagogastric varix rupture, tumor rupture, recurrence of hepatocellular carcinoma and death.(death due to any reason). Change of subjective symptoms.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
LES group: dietary advice and one package of Aminoleban EN as LES before sleep.
Interventions/Control_2
control group: dietary advice only.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who will be receiving radiofrequency ablation for hepatocellular carcinoma.
Key exclusion criteria
1)extrahepatic metastasis
2)portal vein tumor invasion
3)rupture of hepatocellular carcinoma
4)more than 3mg/L of total bilirubin level
5)uncontrollable ascites
6)more than 2mg/L of serum creatinine level
7)history of hepatic coma within a month
8)reconstruction of the biliary tract such as pancreatoduodenectomy
9)allergy for milk (contraindication of Aminoleban EN)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinpei Sato |
Organization
Kyoundo hospital
Division name
gastroenterology and hepatology
Zip code
Address
1-8 Surugadai Kanda Chiyoda-Ku, Tokyo, Japan
TEL
03-3292-2051
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinpei Sato |
Organization
Kyoundo Hospital
Division name
gastroenterology and hepatology
Zip code
Address
1-8 Surugadai Kanda Chiyoda-Ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Division of gastroenterology and hepatology, Kyoundo hospital.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 11 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | 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
Management information
Registered date
| 2011 | Year | 11 | Month | 21 | Day |
Last modified on
| 2011 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007987
