MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShengjing Hospital
About this trial
How to construct a non-invasive, accurate, and convenient method to evaluate the severity of liver fibrosis (LF) is an important general problem in the management of patients with chronic hepatitis B (CHB). We plan to investigate the ability of magnetic resonance elastography (MRE) to grade fibrosis in chronic hepatitis B and apply to clinical longitudinal follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old
Confirmed CHB (laboratory, imaging and clinical tests)
MRE within 6 months before and after liver biopsy
Treatment-naïve
Disqualifiers
Patients with liver malignant tumor
Chronic hepatitis due to other causes (such as alcoholic hepatitis)
CHB combined with hepatitis C, hepatitis D, or HIV
Patients with biliary tract diseases
Trial population
Organize paticipating units to collect standard-of-care data including radiological and clinical data. Patients diagnosed with CHB who received liver biopsy and MRE should be enrolled.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
MRE
DeviceAll imaging studies were performed by using a 1.5T/3.0-T MRI system
Liver biopsy
DeviceLiver biopsy are performed by well-trained pathologists in accordance with standard operating procedures.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Retrospective cohort of patients confirmed diagnosed with chronic hepatitis B2 interventions
Group B: Prospective follow-up cohort of patients confirmed diagnosed with chronic hepatitis B2 interventions
Trial outcomes
Primary outcomes
1
Accuracy of the features of MRE for grading fibrosis in chronic hepatitis B.
WIth liver biopsy as reference standand, the diagnostic perforemace (accuracy) for fibrosis of MRE was assessed.
Time frame
6 monthsSecondary outcomes
1
The efficacy of grading liver fibrosis in CHB patients evaluated by MRE superior to TE and serological indicators (APRI, FIB-4).
WIth liver biopsy as reference standand, the efficacy of MRE, TE and serological indicators (APRI, FIB-4) in evaluating the classification of liver fibrosis were compared.
Time frame
6 months2
The excellent ability of MRE as a non-invasive biomarker for longitudinal monitoring in CHB patients.
WIth QIBA Profile: Magnetic Resonance Elastography of the Liver as reference standand, changes in MRE and liver histology or clinical indicators during follow-up were investigated.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov