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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007227
Receipt No. R000008315
Scientific Title Correlation with Hepato-splenic Stiffness and Hepatic Venous Pressure Gradient and Esohagogastric Varices in the Patients with Chronic Liver Injury via Acoustic Radiation Force Impulse
Date of disclosure of the study information 2012/02/06
Last modified on 2018/09/07

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Basic information
Public title Correlation with Hepato-splenic Stiffness and Hepatic Venous Pressure Gradient and Esohagogastric Varices in the Patients with Chronic Liver Injury via Acoustic Radiation Force Impulse
Acronym HS-HVPG Trial
Scientific Title Correlation with Hepato-splenic Stiffness and Hepatic Venous Pressure Gradient and Esohagogastric Varices in the Patients with Chronic Liver Injury via Acoustic Radiation Force Impulse
Scientific Title:Acronym HS-HVPG 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 hepatic venous pressure gradient with hepato-splenic stiffness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlations of hepatic venous pressure gradient with hepato-splenic stiffness.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 We measure the hepatic venous pressure gradient with ballooncatheter and examine hepato-splenic stiffness via ARFI.
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.Splenectomy or PSE.
2.Portal thrombus
3. Patients who judged inappropriate by researcher.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 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
Organization Kurashiki Central Hospital
Division name Gastroenterology
Zip code
Address
TEL 0864220120
Homepage URL
Email

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
2012 Year 02 Month 06 Day

Related information
URL releasing protocol
Publication of results 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 Completed
Date of protocol fixation
2011 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 02 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
2012 Year 02 Month 04 Day
Last modified on
2018 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008315

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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