UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031374
Receipt number R000035783
Scientific Title Study for the correlation between liver fibrosis, steatosis and prognosis of the patients by using abdominal ultrasonography
Date of disclosure of the study information 2018/03/01
Last modified on 2019/01/17 20:25:34

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Basic information

Public title

Study for the correlation between liver fibrosis, steatosis and prognosis of the patients by using abdominal ultrasonography

Acronym

Study for the correlation between liver fibrosis, steatosis and prognosis of the patients by using abdominal ultrasonography

Scientific Title

Study for the correlation between liver fibrosis, steatosis and prognosis of the patients by using abdominal ultrasonography

Scientific Title:Acronym

Study for the correlation between liver fibrosis, steatosis and prognosis of the patients by using abdominal ultrasonography

Region

Japan


Condition

Condition

liver disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the utility of measuring liver and spleen stiffness and steatosis using ultrasonography as an alternation of liver biopsy, by evaluating the relationship between clinical data and clinical course and investigate the prognosis of patients with liver disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

appearance of liver failure(ascites, edema and rupture of esophageal-gastric varies)

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

all patients those who we operate abdominal ultrasonography

Key exclusion criteria

those who cannot obtain consent to participate in this study

Target sample size

4000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masatoshi Ishigami

Organization

Nagoya university hospital

Division name

department of gastroenterology and hepatology

Zip code


Address

Tsuruma-cho 65, Showa-ku, Nagoya, Aichi

TEL

052-741-2111

Email

masaishi@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Youji Ishizu

Organization

Nagoya university hospital

Division name

department of gastroenterology and hepatology

Zip code


Address

Tsuruma-cho 65, Showa-ku, Nagoya, Aichi

TEL

052-741-2111

Homepage URL


Email

y-ishizu@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

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


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

2018 Year 03 Month 01 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

Open public recruiting

Date of protocol fixation

2018 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 03 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

2018 Year 02 Month 19 Day

Last modified on

2019 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035783


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name