NCT04625166

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
880

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

November 10, 2020

Last Update Submit

January 9, 2021

Conditions

Non Alcoholic Fatty LiverHepatitis BDrug-induced Liver Injury

Keywords

ultrasoundElasticity Imaging Techniques

Outcome Measures

Primary Outcomes (3)

  • F index

    To study the correlation between F index and the degree of fibrosis in patients of chronic liver disease.

    15 minutes

  • A index

    To study the correlation between A index and the degree of hepatitis in patients of chronic liver disease.

    15 minutes

  • ATT index

    To study the correlation between ATT index and the degree of steatosis in patients of metabolic associated fatty liver disease.

    15 minutes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

liver tissue

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseHepatitis BChemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Study Officials

  • Ping Liang, Doctor

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Yu, Doctor

CONTACT

010-66937981yu-jie301@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 12, 2020

Study Start

December 1, 2020

Primary Completion

January 1, 2022

Study Completion

June 30, 2022

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

CN(1)