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

Chronic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653830
• Other study ID #: XJTU1AF2022LSK-300
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Xiaonan Wu
• Phone: 008615686231404
• Email: w793402903[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 ?. Chronic viral hepatitis D ?. Autoimmune liver disease (PBC/AIH/PSC) ?. Non-alcoholic fatty liver disease ?. 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.

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Locations

Country	Name	City	State
China	First Affiliated Hospital Xi'an Jiaotong University	Xi'an

Sponsors (12)

Lead Sponsor

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

3201 Hospital in Hanzhong, Ankang Central Hospital, First Affiliated Hospital of Lanzhou University, First Affiliated Hospital of Xinjiang Medical University, General Hospital of Ningxia Medical University, Second Affiliated Hospital of Lanzhou University, Second Affiliated Hospital of Xi'an Jiaotong University, Tang-Du Hospital, The Fourth People's Hospital of Qinghai Province, Weinan Central Hospital, Yan'an University Affiliated Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality (liver transplantation) rate in patients with chronic liver disease	Clinical data from patients with chronic liver disease are recorded until the patient's death or liver transplantation	10years
Primary	Incidence of liver cancer or decompensated cirrhosis in patients with chronic liver disease	The incidence of progression to liver cancer or decompensated cirrhosis in patients with chronic liver disease was statistically collected	10years
Secondary	Incidence of complications related to cirrhosis	Incidence of various cirrhosis related complications, including infection, hepatic encephalopathy, gastrointestinal bleeding, ascites, hepatorenal syndrome, etc	10years
Secondary	Progression rate of liver fibrosis	The rate of liver fibrosis progression was assessed by liver tissue biopsy results, fibro scan results, FIB-4 score, APRI score, etc	10years