Clinical trial NCT05140837: Early Diagnosis and Timely Treatment of Cirrhotic Patients With Minimal Hepatic Encephalopathy (CHESS-NCRCID 2106)
Official title: Early Diagnosis and Timely Treatment of Cirrhotic Patients With Minimal Hepatic Encephalopathy (CHESS-NCRCID 2106)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatic Encephalopathy
Cirrhosis
Keywords: Minimal hepatic encephalopathy
Cirrhosis
Psychometric hepatic encephalopathy score
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Anhui Medical University
name: Beijing Ditan Hospital
name: Chongqing Public Health Medical Treatment Center
name: Meng Chao Hepatobiliary Hospital of Fujian Medical University
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Shenzhen Third People's Hospital
name: Guizhou people's Hospital
name: Wuhan Union Hospital, China
name: Xiangya Hospital of Central South University
name: The Second Affiliated Hospital of Hainan Medical University
name: The Third Affiliated Hospital of Hebei Medical University
name: The Second Affiliated Hospital of Harbin Medical University
name: Henan Provincial People's Hospital
name: Ganzhou Fifth People's Hospital
name: The First Hospital of Jilin University
name: Jiangsu People's Hospital
name: First Hospital of China Medical University
name: The Second Affiliated Hospital of Baotou Medical College
name: Ningxia Medical University General Hospital
name: The Fourth People's Hospital of Qinghai Province
name: Xi'an High-tech Hospital
name: The 10th People's Hospital affiliated to Tongji University
name: Qilu Hospital of Shandong University
name: The Third People's Hospital of Taiyuan
name: Xichang People's Hospital
name: Tianjin Third Central Hospital
name: The Third People's Hospital of Tibet Autonomous Region
name: Xinjiang Autonomous Region People's Hospital
name: Second People's Hospital of Yunnan Province
name: Hangzhou Xixi hospital
name: LanZhou University
First posted: 2021-12-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cirrhosis

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Psychometric hepatic encephalopathy score (PHES)
timeFrame: 1 year
measure: Clinical decompensation and death
timeFrame: 2 year
measure: EuroQol Five Dimensions Questionnaire (EQ5D)
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Chongqing Public Health Medical Treatment Center
state: Chongqing
city: Fuzhou
country: China
facility: MengChao Hepatobiliary Hospital of Fujian Medical University
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
state: Guangdong
city: Nanning
country: China
facility: Guangxi Zhuang Autonomous Region People's Hospital
state: Guangxi
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical College
state: Hainan
city: Shijiazhuang
country: China
facility: The Third Affiliated Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: The Second Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangsu People's Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: Ganzhou City Fifth People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: Bethune First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Yinchuan
country: China
facility: Ningxia Medical University General Hospital
state: Ningxia
city: Xining
country: China
facility: The Fourth People's Hospital of Qinghai Province
state: Qinghai
city: Xi'an
country: China
facility: Xi'an Hi-tech Hospital
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: The 10th People's Hospital affiliated to Tongji University
state: Shanghai
city: Taiyuan
country: China
facility: The Third People's Hospital of Taiyuan
state: Shanxi
city: Xichang
country: China
facility: Xichang People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
state: Tianjin
city: Lhasa
country: China
facility: The Third People's Hospital of Tibet Autonomous Region
state: Tibetan
city: Ürümqi
country: China
facility: Xinjiang Autonomous Region People's Hospital
state: Xinjiang
city: Kunming
country: China
facility: Second People's Hospital of Yunnan Province
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou Xixi Hospital
state: Zhejiang
Study officials:
affiliation: National Clinical Research Center for Infectious Diseases
name: Fu-Sheng Wang, MD
role: STUDY_CHAIR
affiliation: LanZhou University
name: Xiaolong Qi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Clinical Research Center for Infectious Diseases
name: Jun-Liang Fu, MD
role: PRINCIPAL_INVESTIGATOR
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