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

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.

Conditions

• Hepatic Encephalopathy
• Cirrhosis

Interventions

DIAGNOSTIC_TEST

Psychometric 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.

DRUG

Drug 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 & Collaborators

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Beijing Ditan Hospital

  collaborator OTHER

• Chongqing Public Health Medical Treatment Center

  collaborator UNKNOWN

• Meng Chao Hepatobiliary Hospital of Fujian Medical University

  collaborator OTHER

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Shenzhen Third People's Hospital

  collaborator OTHER

• Guizhou people's Hospital

  collaborator UNKNOWN

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• The Second Affiliated Hospital of Hainan Medical University

  collaborator OTHER

• The Third Affiliated Hospital of Hebei Medical University

  collaborator UNKNOWN

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Ganzhou Fifth People's Hospital

  collaborator UNKNOWN

• The First Hospital of Jilin University

  collaborator OTHER

• Jiangsu People's Hospital

  collaborator UNKNOWN

• First Hospital of China Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Baotou Medical College

  collaborator OTHER

• Ningxia Medical University General Hospital

  collaborator UNKNOWN

• The Fourth People's Hospital of Qinghai Province

  collaborator OTHER

• Xi'an High-tech Hospital

  collaborator UNKNOWN

• The 10th People's Hospital affiliated to Tongji University

  collaborator UNKNOWN

• Qilu Hospital of Shandong University

  collaborator OTHER

• The Third People's Hospital of Taiyuan

  collaborator OTHER

• Xichang People's Hospital

  collaborator UNKNOWN

• Tianjin Third Central Hospital

  collaborator OTHER

• The Third People's Hospital of Tibet Autonomous Region

  collaborator UNKNOWN

• Xinjiang Autonomous Region People's Hospital

  collaborator UNKNOWN

• Second People's Hospital of Yunnan Province

  collaborator OTHER

• Hangzhou Xixi hospital

  collaborator UNKNOWN

• LanZhou University

  collaborator OTHER

• Hepatopancreatobiliary Surgery Institute of Gansu Province

  lead OTHER

Principal Investigators

• Fu-Sheng Wang, MD · National Clinical Research Center for Infectious Diseases

• Xiaolong Qi, MD · LanZhou University

• Jun-Liang Fu, MD · National Clinical Research Center for Infectious Diseases

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-12-09

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• China

Study Locations