Early Diagnosis and Timely Treatment of Cirrhotic Patients With Minimal Hepatic Encephalopathy (CHESS-NCRCID 2106)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Enrolling

Conditions: Hepatic Encephalopathy; Cirrhosis

Treatments: Diagnostic Test: Psychometric hepatic encephalopathy score & Stroop test; Drug: Drug therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05140837

CHESS2106

Details and patient eligibility

About

Hepatic encephalopathy (HE) is a common complication of cirrhosis, which seriously damages the life quality of patients. As the disease progresses, 50-80% of patients with cirrhosis develop HE. Minimal hepatic encephalopathy (MHE) is a manifestation of HE, in which the patient usually has no obvious clinical symptoms and can only be detected by neuropsychological testing. Early identification and timely treatment are the keys to improve the prognosis of HE, and the diagnosis of MHE are the priority in the process of the disease intervention. Guidelines in many countries suggest that MHE does not recommend routine treatment. However, patients with cirrhosis usually have complex clinical complications, so whether timely treatment should be taken remains to be explored. The purpose of this study is to investigate the incidence of MHE in cirrhotic patients, and to establish a real-world cohort for further study on drug therapy and efficacy evaluation.

Full description

According to the 2017 Global Burden of Disease study, there are 10.6 million patients with decompensated cirrhosis and 112 million patients with compensated cirrhosis worldwide. From 1990 to 2016, the number of patients with cirrhosis and chronic liver disease in China has increased from nearly 7 million (6833 300) to nearly 12 million (11 869 600), and the prevalence of all age groups increased by 44%. Hepatic encephalopathy (HE) is a common complication of cirrhosis, which seriously damages the life quality of patients. As the disease progresses, 50-80% of patients with cirrhosis develop HE. Minimal hepatic encephalopathy (MHE) is a manifestation of HE, in which the patient usually has no obvious clinical symptoms and can only be detected by neuropsychological testing. Early identification and timely treatment are the keys to improve the prognosis of HE, and the diagnosis of MHE are the priority in the process of the disease intervention. Guidelines in many countries suggest that MHE does not recommend routine treatment. However, patients with cirrhosis usually have complex clinical complications, so whether timely treatment should be taken remains to be explored. The purpose of this study is to investigate the incidence of MHE in cirrhotic patients, and to establish a real-world cohort for further study on drug therapy and efficacy evaluation.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. age 18-65 years;
2. confirmed cirrhosis based on clinical or pathological criteria;
3. no history of grade 1-4 hepatic encephalopathy;
4. with written informed consent.

Exclusion criteria

1. with other neurological or mental diseases (such as Alzheimer's disease, Parkinson's disease, etc.);
2. with alcohol or drug addiction and unstable vital signs;
3. with liver cancer or other malignant tumors;
4. fail to comply with psychological tests;
5. incomplete data collection.

Trial design

10,000 participants in 2 patient groups

cross-sectional study

Treatment:

Diagnostic Test: Psychometric hepatic encephalopathy score & Stroop test

real-world cohort study

Treatment:

Drug: Drug therapy