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

Study Overview
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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.

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.

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

Conditions
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Hepatic Encephalopathy, Cirrhosis

Intervention / Treatment
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* Diagnostic Test: Psychometric hepatic encephalopathy score & Stroop test
* Drug: Drug therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-65 years; confirmed cirrhosis based on clinical or pathological criteria; no history of grade 1-4 hepatic encephalopathy; with written informed consent. Exclusion Criteria: with other neurological or mental diseases (such as Alzheimer's disease, Parkinson's disease, etc.); with alcohol or drug addiction and unstable vital signs; with liver cancer or other malignant tumors; fail to comply with psychological tests; incomplete data collection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cross-sectional study<br> | Diagnostic Test: Psychometric hepatic encephalopathy score & Stroop test<br>* 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.<br>|
| real-world cohort study<br> | Drug: Drug therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometric hepatic encephalopathy score (PHES) | The PHES is a battery of neuropsychological tests used in the diagnosis of minimal hepatic encephalopathy (MHE). The sum of scores for PHES ranges between +5 and -15. Patients with cirrhosis having a PHES score of <-4 SD are considered to have MHE. | 1 year | 
| Clinical decompensation and death | Clinically evident decompensating events (specifically ascites, variceal hemorrhage). | 2 year | 
| EuroQol Five Dimensions Questionnaire (EQ5D) | EQ5D is used to evaluate the quality of life. EQ-5D consists of two main parts: Descriptive System and Visual Analogue Scale. Five dimensions are used to describe the health state: Mobility, self-care, Usual Activities, Pain/Discomfort, Anxiety/Depression. A scale ranges from 0 to 100, with 0 representing your worst imagined health and 100 your best imagined health. Self-rated information from respondents can be used as a quantitative indicator of health outcomes. | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimal hepatic encephalopathy, Cirrhosis, Psychometric hepatic encephalopathy score