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临床试验/NCT05140837
NCT05140837招募中不适用

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

Hepatopancreatobiliary Surgery Institute of Gansu Province31 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2021年12月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
31
主要终点
Psychometric hepatic encephalopathy score (PHES)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-65 years;
  • confirmed cirrhosis based on clinical or pathological criteria;
  • no history of grade 1-4 hepatic encephalopathy;
  • with written informed consent.

排除标准

  • 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.

研究组 & 干预措施

cross-sectional study

干预措施: Psychometric hepatic encephalopathy score & Stroop test (Diagnostic Test)

real-world cohort study

干预措施: Drug therapy (Drug)

结局指标

主要结局

Psychometric hepatic encephalopathy score (PHES)

时间窗: 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

时间窗: 2 year

Clinically evident decompensating events (specifically ascites, variceal hemorrhage).

EuroQol Five Dimensions Questionnaire (EQ5D)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Hepatopancreatobiliary Surgery Institute of Gansu Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaolong Qi

Chief

Hepatopancreatobiliary Surgery Institute of Gansu Province

研究点 (31)

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