A Nomogram for Evaluating Significant Liver Fibrosis in Patients With Chronic Hepatitis B Virus Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

259 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2022-05-30

Brief Summary

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Liver fibrosis is the key step for progression to cirrhosis and liver cancer in patients with chronic hepatitis B (CHB). It is crucial to identify significant liver fibrosis in the treatment of CHB patients. Hence, the investigators aim to construct and validate a new nomogram model for evaluating significant liver fibrosis in CHB patients. The nomogram was based on a retrospective study of 259 CHB patients, who underwent liver biopsy. Through random grouping, 182 cases (70%) were included in the training set and 77 cases (30%) were included in the validation set. Biopsy pathological stage was used as the gold standard to screen the factors included in the model. The receiver operating characteristic (ROC), area under the ROC curve (AUC), calibration curve, and decision curve analysis were used to evaluate the diagnostic effect of this nomogram model. In addition, the investigators will compare the diagnostic efficiency of the new nomogram model with APRI, FIB-4, and GPR.

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Detailed Description

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Conditions

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Liver Fibrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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significant liver fibrosis

According to the Scheuer scoring system, the degree of fibrosis S2-S4 as significant liver fibrosis.

No interventions assigned to this group

non-significant liver fibrosis

According to the Scheuer scoring system, the degree of fibrosis S0-S1 was defined as non-significant liver fibrosis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* meet the diagnostic standard presented in Asian-Pacific clinical practice guidelines on the management of hepatitis B.
* HBsAg-positive for over 6 months.
* aged 18-65 years old.
* no gender limitation.

Exclusion Criteria

* co-infection with other types of hepatitis viruses, including types A, C, D, and E.
* co-infection with human immunodeficiency virus (HIV).
* autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), inherited metabolic liver disease, drug-induced liver injury (DILI), alcoholic liver disease, and hepatocellular carcinoma (HCC).
* with other malignant tumor and other major systemic diseases.
* incomplete clinical data.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No