Cirrhosis, Hepatic Encephalopathy
Conditions
Keywords
Minimal hepatic encephalopathy, Cirrhosis, Psychometric hepatic encephalopathy score
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.
Interventions
DIAGNOSTIC_TESTPsychometric 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.
DRUGDrug 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.
Sponsors
The First Affiliated Hospital of Anhui Medical University
Beijing Ditan Hospital
Chongqing Public Health Medical Treatment Center
Meng Chao Hepatobiliary Hospital of Fujian Medical University
People's Hospital of Guangxi Zhuang Autonomous Region
Shenzhen Third People's Hospital
Guizhou people's Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Xiangya Hospital of Central South University
The Second Affiliated Hospital of Hainan Medical University
The Third Affiliated Hospital of Hebei Medical University
The Second Affiliated Hospital of Harbin Medical University
Henan Provincial People's Hospital
Ganzhou Fifth People's Hospital
The First Hospital of Jilin University
Jiangsu People's Hospital
First Hospital of China Medical University
The Second Affiliated Hospital of Baotou Medical College
Ningxia Medical University General Hospital
The Fourth People's Hospital of Qinghai Province
Xi'an High-tech Hospital
The 10th People's Hospital affiliated to Tongji University
Qilu Hospital of Shandong University
The Third People's Hospital of Taiyuan
Xichang People's Hospital
Tianjin Third Central Hospital
The Third People's Hospital of Tibet Autonomous Region
Xinjiang Autonomous Region People's Hospital
Second People's Hospital of Yunnan Province
Hangzhou Xixi hospital
LanZhou University
Hepatopancreatobiliary Surgery Institute of Gansu Province
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactXiaolong Qi
Outcome results
None listed