Early Diagnosis and Timely Treatment of Cirrhotic Patients With Minimal Hepatic Encephalopathy (CHESS-NCRCID 2106)
- Conditions
- CirrhosisHepatic Encephalopathy
- Interventions
- Diagnostic Test: Psychometric hepatic encephalopathy score & Stroop testDrug: Drug therapy
- Registration Number
- NCT05140837
- Lead Sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- age 18-65 years;
- confirmed cirrhosis based on clinical or pathological criteria;
- no history of grade 1-4 hepatic encephalopathy;
- with written informed consent.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description cross-sectional study Psychometric hepatic encephalopathy score & Stroop test - real-world cohort study Drug therapy -
- Primary Outcome Measures
Name Time Method Psychometric hepatic encephalopathy score (PHES) 1 year 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.
Clinical decompensation and death 2 year Clinically evident decompensating events (specifically ascites, variceal hemorrhage).
EuroQol Five Dimensions Questionnaire (EQ5D) 2 year 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Ditan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Chongqing Public Health Medical Treatment Center
🇨🇳Chongqing, Chongqing, China
MengChao Hepatobiliary Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Shenzhen Third People's Hospital
🇨🇳Shenzhen, Guangdong, China
Guangxi Zhuang Autonomous Region People's Hospital
🇨🇳Nanning, Guangxi, China
Guizhou Provincial People's Hospital
🇨🇳Guiyang, Guizhou, China
The Second Affiliated Hospital of Hainan Medical College
🇨🇳Haikou, Hainan, China
The Third Affiliated Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Scroll for more (21 remaining)The First Affiliated Hospital of Anhui Medical University🇨🇳Hefei, Anhui, ChinaYufeng Gao, MDContact