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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006753
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Division of gastroenterology and hepatology, Kyoundo hospital.
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007987

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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