Observational Clinical Study of the Natural Course and Long-term Prognosis of Patients With Chronic Liver Disease

Recruiting

• Conditions: Chronic Liver Disease

• Registration Number: NCT05653830
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

Chronic liver disease is a global public health problem. Without timely diagnosis and treatment, chronic liver disease can progress to hepatitis, liver fibrosis, and cirrhosis, while causing a variety of complications such as gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, and liver cancer. Early detection and treatment can slow down the progression of chronic liver disease and reduce the burden of patients. This study intends to construct a retrospective-prospective cohort of patients with chronic liver disease by building a multicenter collaborative network to study the disease characteristics, progression patterns, clinical features, natural course and long-term prognosis of chronic liver disease of different etiologies.

Detailed Description

Different etiologies can lead to chronic liver disease, and common causes include non-alcoholic fatty liver disease (NAFLD), hepatitis B virus (HBV), hepatitis C virus (HCV), alcohol-related liver disease (ALD), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC) and autoimmune hepatitis (AIH). In recent years, with the popularization of HBV vaccination and the advancement of drugs for the treatment of viral hepatitis, the incidence of cirrhosis has been curbed in many countries, but obesity, metabolic syndrome and alcohol abuse have led to an increase in the incidence of NAFLD and ALD recently. The large number of patients with cirrhosis causes loss of social workforce and depletion of medical resources, as well as increased family stress and reduced quality of life. As a result of that, cirrhosis remains a public health problem that cannot be ignored.

To better understand the natural course and clinical characteristics of chronic liver disease due to different etiologies, this study proposes to establish a multicenter, large sample, long-term follow-up cohort of patients with chronic liver disease to improve the clinical data related to chronic liver disease in China. This cohort study will help us to better manage patients with chronic liver disease and build on this foundation for epidemiology, interventions, and prognosis of chronic liver disease. The cohort and experience generated from this study serves as a support for a series of future studies to focus on clinical issues such as low-level viremia, other complications of cirrhosis, liver failure, end-stage liver disease, and liver cancer.

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-10-01
• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-09
• Last Update Submitted: 2022-12-09
• Study First Posted: 2022-12-16
• Last Update Posted: 2022-12-16
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50000

Inclusion Criteria

1. Patients who regularly visit and follow up at the corresponding liver disease center

2. All patients meet at least one of the following diagnostic criteria for chronic liver disease:

   • Chronic viral hepatitis B

     • Chronic viral hepatitis C ③. Chronic viral hepatitis D ④. Autoimmune liver disease (PBC/AIH/PSC) ⑤. Non-alcoholic fatty liver disease ⑥. Alcoholic liver disease

Exclusion Criteria

1. First visit diagnosed with hepatocellular carcinoma or after liver transplantation.
2. Combined with other advanced malignant tumors.
3. The patient refused to sign the informed consent form to participate in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality (liver transplantation) rate in patients with chronic liver disease	10years	Clinical data from patients with chronic liver disease are recorded until the patient's death or liver transplantation
Incidence of liver cancer or decompensated cirrhosis in patients with chronic liver disease	10years	The incidence of progression to liver cancer or decompensated cirrhosis in patients with chronic liver disease was statistically collected

Secondary Outcome Measures

Name	Time	Method
Progression rate of liver fibrosis	10years	The rate of liver fibrosis progression was assessed by liver tissue biopsy results, fibro scan results, FIB-4 score, APRI score, etc
Incidence of complications related to cirrhosis	10years	Incidence of various cirrhosis related complications, including infection, hepatic encephalopathy, gastrointestinal bleeding, ascites, hepatorenal syndrome, etc

Trial Locations

Locations (1)

First Affiliated Hospital Xi'an Jiaotong University; 🇨🇳 Xi'an, China