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.
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.
Study Type
OBSERVATIONAL
Enrollment
10,000
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. 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.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGBeijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChongqing Public Health Medical Treatment Center
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGMengChao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
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.
Time frame: 1 year
Clinical decompensation and death
Clinically evident decompensating events (specifically ascites, variceal hemorrhage).
Time frame: 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.
Time frame: 2 year
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The First Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGShenzhen Third People's Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGGuangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGGuizhou Provincial People's Hospital
Guiyang, Guizhou, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Hainan Medical College
Haikou, Hainan, China
NOT_YET_RECRUITINGThe Third Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITING...and 21 more locations