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

NCT05140837 | Unknown DMC

• 1 other identifier: CHESS2106
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 31

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.

Conditions

Hepatic Encephalopathy; Cirrhosis

Keywords

Minimal hepatic encephalopathy; Cirrhosis; Psychometric hepatic encephalopathy score

Outcome Measures

Primary Outcomes (3)

• Psychometric hepatic encephalopathy score (PHES)

  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.

  1 year

• Clinical decompensation and death

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

  2 year

• EuroQol Five Dimensions Questionnaire (EQ5D)

  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.

  2 year

Study Arms (2)

cross-sectional study

Diagnostic Test: Psychometric hepatic encephalopathy score & Stroop test

real-world cohort study

Drug: Drug therapy

Interventions

Psychometric hepatic encephalopathy score & Stroop test DIAGNOSTIC_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.

cross-sectional study

Drug therapy DRUG

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.

real-world cohort study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cirrhosis

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Beijing Ditan Hospital: collaborator
• Chongqing Public Health Medical Treatment Center: collaborator
• Meng Chao Hepatobiliary Hospital of Fujian Medical University: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Shenzhen Third People's Hospital: collaborator
• Guizhou people's Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Xiangya Hospital of Central South University: collaborator
• The Second Affiliated Hospital of Hainan Medical University: collaborator
• The Third Affiliated Hospital of Hebei Medical University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• Henan Provincial People's Hospital: collaborator
• Ganzhou Fifth People's Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Jiangsu People's Hospital: collaborator
• First Hospital of China Medical University: collaborator
• The Second Affiliated Hospital of Baotou Medical College: collaborator
• Ningxia Medical University General Hospital: collaborator
• The Fourth People's Hospital of Qinghai Province: collaborator
• Xi'an High-tech Hospital: collaborator
• The 10th People's Hospital affiliated to Tongji University: collaborator
• Qilu Hospital of Shandong University: collaborator
• The Third People's Hospital of Taiyuan: collaborator
• Xichang People's Hospital: collaborator
• Tianjin Third Central Hospital: collaborator
• The Third People's Hospital of Tibet Autonomous Region: collaborator
• Xinjiang Autonomous Region People's Hospital: collaborator
• Second People's Hospital of Yunnan Province: collaborator
• Hangzhou Xixi hospital: collaborator
• LanZhou University: collaborator

Study Sites (31)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

NOT YET RECRUITING

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Chongqing Public Health Medical Treatment Center

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

MengChao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

NOT YET RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

RECRUITING

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

NOT YET RECRUITING

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, China

NOT YET RECRUITING

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

NOT YET RECRUITING

The Second Affiliated Hospital of Hainan Medical College

Haikou, Hainan, China

NOT YET RECRUITING

The Third Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

NOT YET RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

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

Wuhan, Hubei, China

NOT YET RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

NOT YET RECRUITING

The Second Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China

NOT YET RECRUITING

Jiangsu People's Hospital

Nanjing, Jiangsu, China

NOT YET RECRUITING

Ganzhou City Fifth People's Hospital

Ganzhou, Jiangxi, China

NOT YET RECRUITING

Bethune First Hospital of Jilin University

Changchun, Jilin, China

NOT YET RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

NOT YET RECRUITING

Ningxia Medical University General Hospital

Yinchuan, Ningxia, China

NOT YET RECRUITING

The Fourth People's Hospital of Qinghai Province

Xining, Qinghai, China

NOT YET RECRUITING

Xi'an Hi-tech Hospital

Xi'an, Shaanxi, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

The 10th People's Hospital affiliated to Tongji University

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

The Third People's Hospital of Taiyuan

Taiyuan, Shanxi, China

NOT YET RECRUITING

Xichang People's Hospital

Xichang, Sichuan, China

NOT YET RECRUITING

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

The Third People's Hospital of Tibet Autonomous Region

Lhasa, Tibetan, China

NOT YET RECRUITING

Xinjiang Autonomous Region People's Hospital

Ürümqi, Xinjiang, China

NOT YET RECRUITING

Second People's Hospital of Yunnan Province

Kunming, Yunnan, China

NOT YET RECRUITING

Hangzhou Xixi Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Related Publications (13)

• GBD 2017 Cirrhosis Collaborators. The global, regional, and national burden of cirrhosis by cause in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):245-266. doi: 10.1016/S2468-1253(19)30349-8. Epub 2020 Jan 22.

  PMID: 31981519 BACKGROUND

• Li M, Wang ZQ, Zhang L, Zheng H, Liu DW, Zhou MG. Burden of Cirrhosis and Other Chronic Liver Diseases Caused by Specific Etiologies in China, 1990-2016: Findings from the Global Burden of Disease Study 2016. Biomed Environ Sci. 2020 Jan 20;33(1):1-10. doi: 10.3967/bes2020.001.

  PMID: 32029053 BACKGROUND

• Xiao J, Wang F, Wong NK, He J, Zhang R, Sun R, Xu Y, Liu Y, Li W, Koike K, He W, You H, Miao Y, Liu X, Meng M, Gao B, Wang H, Li C. Global liver disease burdens and research trends: Analysis from a Chinese perspective. J Hepatol. 2019 Jul;71(1):212-221. doi: 10.1016/j.jhep.2019.03.004. Epub 2019 Mar 12.

  PMID: 30871980 BACKGROUND

• Zimmermann M, Reichert AS. Rapid metabolic and bioenergetic adaptations of astrocytes under hyperammonemia - a novel perspective on hepatic encephalopathy. Biol Chem. 2021 Jul 30;402(9):1103-1113. doi: 10.1515/hsz-2021-0172. Print 2021 Aug 26.

  PMID: 34331848 BACKGROUND

• Bale A, Pai CG, Shetty S, Balaraju G, Shetty A. Prevalence of and Factors Associated With Minimal Hepatic Encephalopathy in Patients With Cirrhosis of Liver. J Clin Exp Hepatol. 2018 Jun;8(2):156-161. doi: 10.1016/j.jceh.2017.06.005. Epub 2017 Jun 20.

  PMID: 29892178 BACKGROUND

• Sharma K, Pant S, Misra S, Dwivedi M, Misra A, Narang S, Tewari R, Bhadoria AS. Effect of rifaximin, probiotics, and l-ornithine l-aspartate on minimal hepatic encephalopathy: a randomized controlled trial. Saudi J Gastroenterol. 2014 Jul-Aug;20(4):225-32. doi: 10.4103/1319-3767.136975.

  PMID: 25038208 BACKGROUND

• Cabrera-Pastor A, Llansola M, Montoliu C, Malaguarnera M, Balzano T, Taoro-Gonzalez L, Garcia-Garcia R, Mangas-Losada A, Izquierdo-Altarejos P, Arenas YM, Leone P, Felipo V. Peripheral inflammation induces neuroinflammation that alters neurotransmission and cognitive and motor function in hepatic encephalopathy: Underlying mechanisms and therapeutic implications. Acta Physiol (Oxf). 2019 Jun;226(2):e13270. doi: 10.1111/apha.13270. Epub 2019 Mar 22.

  PMID: 30830722 BACKGROUND

• Wang JY, Zhang NP, Chi BR, Mi YQ, Meng LN, Liu YD, Wang JB, Jiang HX, Yang JH, Xu Y, Li X, Xu JM, Zhang G, Zhou XM, Zhuge YZ, Tian DA, Ye J, Liu YL. Prevalence of minimal hepatic encephalopathy and quality of life evaluations in hospitalized cirrhotic patients in China. World J Gastroenterol. 2013 Aug 14;19(30):4984-91. doi: 10.3748/wjg.v19.i30.4984.

  PMID: 23946605 BACKGROUND

• Xu XY, Ding HG, Li WG, Jia JD, Wei L, Duan ZP, Liu YL, Ling-Hu EQ, Zhuang H, Hepatology CSO, Association CM. Chinese guidelines on management of hepatic encephalopathy in cirrhosis. World J Gastroenterol. 2019 Sep 28;25(36):5403-5422. doi: 10.3748/wjg.v25.i36.5403.

  PMID: 31576089 BACKGROUND

• Flud CR, Duarte-Rojo A. Prognostic Implications of Minimal/Covert Hepatic Encephalopathy: Large-scale Validation Cohort Studies. J Clin Exp Hepatol. 2019 Jan-Feb;9(1):112-116. doi: 10.1016/j.jceh.2018.04.009. Epub 2018 May 4.

  PMID: 30765944 BACKGROUND

• Bajaj JS, Lauridsen M, Tapper EB, Duarte-Rojo A, Rahimi RS, Tandon P, Shawcross DL, Thabut D, Dhiman RK, Romero-Gomez M, Sharma BC, Montagnese S. Important Unresolved Questions in the Management of Hepatic Encephalopathy: An ISHEN Consensus. Am J Gastroenterol. 2020 Jul;115(7):989-1002. doi: 10.14309/ajg.0000000000000603.

  PMID: 32618647 BACKGROUND

• Reuter B, Walter K, Bissonnette J, Leise MD, Lai J, Tandon P, Kamath PS, Biggins SW, Rose CF, Wade JB, Bajaj JS. Assessment of the spectrum of hepatic encephalopathy: A multicenter study. Liver Transpl. 2018 May;24(5):587-594. doi: 10.1002/lt.25032.

  PMID: 29457869 BACKGROUND

• Li XY, Liu SH, Liu C, Zu HM, Guo XQ, Xiang HL, Huang Y, Yan ZL, Li YJ, Sun J, Song RX, Yan JQ, Ye Q, Liu F, Huang L, Meng FP, Zhang XN, Yang SS, Hu SJ, Ruan JG, Li YL, Wang NN, Cui HP, Wang YM, Lei C, Wang QH, Tian HL, Qu ZS, Yuan M, Shi RC, Yang XT, Jin D, Su D, Liu YJ, Chen Y, Xia YX, Li YZ, Yang QH, Li H, Zhao XL, Tian ZM, Yu HJ, Zhang XJ, Wu CX, Wu ZJ, Li SS, Shen Q, Liu XM, Hu JP, Wu MQ, Dang T, Wang J, Meng XM, Wang HY, Jiang ZY, Liu YY, Liu Y, Qu SX, Tao H, Yan DM, Liu J, Fu W, Yu J, Wang FS, Qi XL, Fu JL. [Impact of different diagnostic criteria for assessing mild micro-hepatic encephalopathy in liver cirrhosis: an analysis based on a prospective, multicenter, real-world study]. Zhonghua Gan Zang Bing Za Zhi. 2023 Sep 20;31(9):961-968. doi: 10.3760/cma.j.cn501113-20220602-00298. Chinese.

  PMID: 37872092 DERIVED

MeSH Terms

Conditions

Hepatic Encephalopathy; Fibrosis

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Fu-Sheng Wang, MD

  National Clinical Research Center for Infectious Diseases

  STUDY CHAIR

• Xiaolong Qi, MD

  LanZhou University

  PRINCIPAL INVESTIGATOR

• Jun-Liang Fu, MD

  National Clinical Research Center for Infectious Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolong Qi

CONTACT

8618588602600; qixiaolong@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: December 1, 2021
• Study Start: December 9, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (31)