Combi-elastography Assessment of Chronic Liver Disease Multi-center Study

January 9, 2021 updated by: Ping Liang, Chinese PLA General Hospital
HITACH developed a new combi-elastography imaging technology combines shear wave imaging and strain imaging technology. In the study, not only the F index which is related to the stage of liver fibrosis can be obtained, but also the A index which is related to the stage of hepatitis can be obtained, which can not be obtained by other ultrasound devices.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

HITACHI developed a new combi-elastography imaging technology combines shear wave imaging and strain imaging technology to make full use of these two imaging modalities and make full use of different physical characteristics for imaging and quantitative analysis.

In the study, not only the F index which is related to the stage of liver fibrosis can be obtained, but also the A index which is related to the stage of hepatitis can be obtained, which can not be obtained by other ultrasound devices.

This technology is non-invasive, painless, simple and reliable, therefore it is bound to contribute to the early diagnosis of chronic liver disease and the real-time evaluation in the treatment process, which will play an important role in the clinical application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
880

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are eligible for the inclusion criteria as well as the exclusion criteria are enrolled in this study to obtain their clinical information.

Description

Inclusion Criteria:

  • Patients with chronic hepatitis B:18-80 years old, no gender limit;Patient with chronic hepatitis B was diagnosed by liver histopathological examination;The pathological examination of liver tissue clearly provides G/S classification information. If there is steatosis, classification information is required;Patients without prehepatic ascites;Sign informed consent.
  • Patients with MAFLD:18-80 years old, no gender limit;Meet the diagnostic criteria for metabolic-related fatty liver disease:Liver histological examination has liver steatosis,and meet one of the following three criteria,that is, overweight/obesity,type 2 diabetes (T2DM) or abnormal metabolism;Liver histopathological examination provides information on the classification of liver cell steatosis, fibrosis, and inflammation clearly;Patients without prehepatic ascites;Sign informed consent;
  • Patients with DILI:18-80 years old, no gender limit;Patients with drug-induced liver injury was diagnosed by liver histological examination;The pathological examination of liver tissue provides G/S classification information clearly,If there is liver cell steatosis, classification information is required;Patients without prehepatic ascites;Sign informed consent;
  • Healthy volunteers:Aged 18 to 60,Gender not limited,BMI<25;No abnormal signs by clinical examination,no fatty liver, No history of chronic liver disease such as hepatitis and liver cirrhosis, no serious gastrointestinal disease;Without metabolic syndrome;There is no history of long-term medication,do not taking any drugs before a month when checking;Did not find the primary lesions of liver, laboratory examination and clinical diagnosis without any liver disease and liver function is normal;Sign the informed consent.

Exclusion Criteria:

  • Patients with chronic hepatitis B:Merging other disease caused by chronic liver disease (such as other types of viral hepatitis, drug-induced liver injury, autoimmune liver disease, alcoholic liver disease, metabolic related);Merging other systems' serious illness can't cooperate with elastic imaging checking (such as heart failure, renal failure,mental illness);Patients after liver transplantation;Pregnancy patients.
  • Patients with MAFLD:Did/ongoing systemic chemotherapy patients;Patients with hepatic steatosis because of alcoholic liver disease,Viral hepatitis,Drug-induced liver disease,Autoimmune hepatitis or hepatolenticular degeneration et al;Special fatty liver disease cases because of drugs, total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism,Cushing's syndrome,β lipoprotein lack hematic disease,Lipid atrophic diabetes or Mauriac syndrome et al;Merging other systems serious illness can't cooperate with elastic imaging checking(such as heart failure, renal failure,mental illness) ; Patients after liver transplantation;Patients with pregnancy.
  • Patients with DILI:Other reasons or combined with other reasons caused liver damage (such as viral hepatitis, autoimmune liver disease, alcoholic liver disease, metabolic related fatty liver disease);The liver local infection and systemic infection;Merging other systems serious illness can't cooperate with elastic imaging checking(such as heart failure, renal failure,mental illness) ; Patients after liver transplantation;Patients with pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
F index
Time Frame: 15 minutes
To study the correlation between F index and the degree of fibrosis in patients of chronic liver disease.
15 minutes
A index
Time Frame: 15 minutes
To study the correlation between A index and the degree of hepatitis in patients of chronic liver disease.
15 minutes
ATT index
Time Frame: 15 minutes
To study the correlation between ATT index and the degree of steatosis in patients of metabolic associated fatty liver disease.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S2020-387-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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