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

Central South University

Status: Completed

Conditions: Liver Fibrosis

Study type: Observational

Funder types: Other

Identifiers

NCT05560503

202205120

Details and patient eligibility

About

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.

Enrollment: 259 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

259 participants in 2 patient groups

significant liver fibrosis

Description:

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

non-significant liver fibrosis

Description:

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