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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-09

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatic Encephalopathy Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cross-sectional study

Psychometric hepatic encephalopathy score & Stroop test

Intervention Type DIAGNOSTIC_TEST

MHE was assessed according to neuropsychological methods. Psychometric hepatic encephalopathy score include number connection test (NCT), digit-symbol test (DST), line-tracing test (LTT) and serial dotting test (SDT). Stroop test can assess psychomotor speed and cognitive flexibility by recording the interference response time between recognizing color fields and writing color names.

real-world cohort study

Drug therapy

Intervention Type DRUG

Real-world cohort study. The outcomes were examined and registered, so as to evaluate the relationship between therapeutic effects and health outcomes. Psychometric hepatic encephalopathy score and quality of life scale were measured at 3, 6, 12, 18 and 24 months of follow-up.

Interventions

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Psychometric hepatic encephalopathy score & Stroop test

MHE was assessed according to neuropsychological methods. Psychometric hepatic encephalopathy score include number connection test (NCT), digit-symbol test (DST), line-tracing test (LTT) and serial dotting test (SDT). Stroop test can assess psychomotor speed and cognitive flexibility by recording the interference response time between recognizing color fields and writing color names.

Intervention Type DIAGNOSTIC_TEST

Drug therapy

Real-world cohort study. The outcomes were examined and registered, so as to evaluate the relationship between therapeutic effects and health outcomes. Psychometric hepatic encephalopathy score and quality of life scale were measured at 3, 6, 12, 18 and 24 months of follow-up.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Xiaolong Qi

Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fu-Sheng Wang, MD

Role: STUDY_CHAIR

National Clinical Research Center for Infectious Diseases

Xiaolong Qi, MD

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Jun-Liang Fu, MD

Role: PRINCIPAL_INVESTIGATOR

National Clinical Research Center for Infectious Diseases

Locations

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