Clinical trial NCT05653830: Observational Clinical Study of the Natural Course and Long-term Prognosis of Patients With Chronic Liver Disease
Official title: Multicenter, Retrospective-prospective, Observational Clinical Study of the Natural Course and Long-term Prognosis of Patients With Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Liver Disease
Keywords: retrospective-prospective, observational clinical study of chronic liver disease
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Ankang Central Hospital
name: 3201 Hospital in Hanzhong
name: Weinan Central Hospital
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Tang-Du Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: General Hospital of Ningxia Medical University
name: Lanzhou University Second Hospital
name: First Affiliated Hospital of Lanzhou University
name: The Fourth People's Hospital of Qinghai Province
name: Yan'an University Affiliated Hospital
First posted: 2022-12-16
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long-term follow-up of patients with chronic liver disease managed by liver disease centers and infectious disease centers in Shaanxi, Ningxia, Gansu, Qinghai, Xinjiang and other places

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality (liver transplantation) rate in patients with chronic liver disease
timeFrame: 10years
measure: Incidence of liver cancer or decompensated cirrhosis in patients with chronic liver disease
timeFrame: 10years
Secondary outcomes:
measure: Incidence of complications related to cirrhosis
timeFrame: 10years
measure: Progression rate of liver fibrosis
timeFrame: 10years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital Xi'an Jiaotong University
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yingli He
role: STUDY_CHAIR
References: