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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05653830
Enrollment
50000
Registered
2022-12-16
Start date
2022-10-01
Completion date
2025-12-31
Last updated
2022-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Disease

Keywords

retrospective-prospective, observational clinical study of chronic liver disease

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mortality (liver transplantation) rate in patients with chronic liver disease10yearsClinical 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 disease10yearsThe incidence of progression to liver cancer or decompensated cirrhosis in patients with chronic liver disease was statistically collected

Secondary

MeasureTime frameDescription
Incidence of complications related to cirrhosis10yearsIncidence of various cirrhosis related complications, including infection, hepatic encephalopathy, gastrointestinal bleeding, ascites, hepatorenal syndrome, etc
Progression rate of liver fibrosis10yearsThe rate of liver fibrosis progression was assessed by liver tissue biopsy results, fibro scan results, FIB-4 score, APRI score, etc

Countries

China

Contacts

Primary ContactXiaonan Wu
w793402903@163.com008615686231404
Backup ContactYingli He
heyingli2000@163.com008618991232863

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026