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

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ClinicalTrials.gov Identifier: NCT04625166
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Ping Liang, Chinese PLA General Hospital

Study Description
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Brief Summary:
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.

Condition or disease
Non Alcoholic Fatty Liver Hepatitis B Drug-induced Liver Injury

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 Design
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Study Type : Observational
Estimated Enrollment : 880 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Combi-elastography Assessment of Chronic Liver Disease Multi-center Study
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. F index [ Time Frame: 15 minutes ]
    To study the correlation between F index and the degree of fibrosis in patients of chronic liver disease.

  2. A index [ Time Frame: 15 minutes ]
    To study the correlation between A index and the degree of hepatitis in patients of chronic liver disease.

  3. 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.


Biospecimen Retention:   Samples Without DNA
liver tissue

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625166


Contacts
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Contact: Jie Yu, Doctor 010-66937981 yu-jie301@hotmail.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Ping Liang, Doctor         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Ping Liang, Doctor Chinese PLA General Hospital
More Information
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Responsible Party: Ping Liang, Chief physician, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT04625166    
Other Study ID Numbers: S2020-387-01
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ping Liang, Chinese PLA General Hospital:
ultrasound
Elasticity Imaging Techniques
Additional relevant MeSH terms:
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Hepatitis B
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Chemical and Drug Induced Liver Injury
Hepatitis
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
 Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning