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

NCT05560503 | Completed

• 1 other identifier: 202205120
• Study Type: observational
• Target: 259
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Fibrosis

Outcome Measures

Primary Outcomes (1)

• Differences in demographic data and clinical test indicators between significant liver fibrosis group and non-significant liver fibrosis group

  Demographic data include age and sex. Dlinical test indicators include albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyl transferase, alkaline phosphatase, white blood cell count, neutrophil count, hemoglobin, platelet count, prothrombin activity, international normalized ratio, activated partial thromboplastin time, alpha fetoprotein, HBV DNA, HBsAg, and HBeAg.

  0 week

Study Arms (2)

significant liver fibrosis

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

non-significant liver fibrosis

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From January 2017 to May 2022, a total of 259 patients with chronic hepatitis B who underwent liver biopsy, in Xiangya Hospital of Central South University, were retrospectively reviewed.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 29, 2022
• Study Start: January 1, 2017
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL