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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    10000
  • sponsor
    Hepatopancreatobiliary Surgery Institute of Gansu Province
Updated on 25 March 2022
encephalopathy
cirrhosis
psychometric testing
minimal hepatic encephalopathy
Accepts healthy volunteers

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.

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.

Details
Condition Hepatic Encephalopathy, Cirrhosis
Treatment Drug therapy, Psychometric hepatic encephalopathy score & Stroop test
Clinical Study IdentifierNCT05140837
SponsorHepatopancreatobiliary Surgery Institute of Gansu Province
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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