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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004363
Receipt No. R000005170
Scientific Title Risk of Hepatocellular Carcinoma or Decompensated Liver Cirrhosis in Patients with Chronic Liver Injury via Virtual Touch Tissue Quantification
Date of disclosure of the study information 2010/10/12
Last modified on 2012/04/08

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Basic information
Public title Risk of Hepatocellular Carcinoma or Decompensated Liver Cirrhosis in Patients with Chronic Liver Injury via Virtual Touch Tissue Quantification
Acronym HCC DLC-VTTQ Trial
Scientific Title Risk of Hepatocellular Carcinoma or Decompensated Liver Cirrhosis in Patients with Chronic Liver Injury via Virtual Touch Tissue Quantification
Scientific Title:Acronym HCC DLC-VTTQ Trial
Region
Japan

Condition
Condition Patients with chronic liver injury or liver cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the correlations of risk of decompensated liver cirrhosis(esophageal varices, ascites, and hepatic encephalopathy) and HCC with hepato-splenic virtual touch tissue quantification and hepato-splenic arterial resistance in patients with chronic liver injury
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Complication of decompenseted cirrhosis and HCC.
2.Development of decompenseted cirrhosis and HCC.
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients with chronic liver injury or liver cirrhosis
2.We do not ask whether etiology of chronic liver injury or liver cirrhosis.
3.Patients received document agreement with participation in this study.
Key exclusion criteria 1.A pregnant woman and the patients with the pregnant possibility or the patients nursing a baby.
2.Contraindication of liver biopsy or liver resection.
3.Splenectomy or PSE.
4. Patients who judged inappropriate by researcher.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Youichi Morimoto and Yoshitaka Takuma
Organization Kurashiki Central Hospital
Division name Gastroenterology
Zip code
Address 1-1-1,Miwa, Kurashiki, Okayama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Rui Tamura
Organization Kurashiki Central Hospital
Division name Gastroenterology
Zip code
Address
TEL
Homepage URL
Email rt12966@kchnet.or.jp

Sponsor
Institute Department Gastroenterology,Kurashiki Central Hospital
Institute
Department

Funding Source
Organization Kurashiki Central Hospital
Organization
Division
Category of Funding Organization Non profit foundation
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
2010 Year 10 Month 12 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
2010 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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 1.Primary Endpoint
We examine the correlations of risk of decompensated liver cirrhosis(esophageal varices, ascites, and hepatic encephalopathy) and HCC with hepato-splenic virtual touch tissue quantification and hepato-splenic arterial resistance in patients with chronic liver injury arterial resistance.
2.Observational period is 3 years

Management information
Registered date
2010 Year 10 Month 08 Day
Last modified on
2012 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005170

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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