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Hepatic EncephalopathyNCT05140837

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

An observational study of Hepatic Encephalopathy and Cirrhosis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 31 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Encephalopathy, Cirrhosis
What is being tested?
Psychometric hepatic encephalopathy score & Stroop test and Drug therapy
How many people
10,000 participants
Where
31 sitesChina
Study dates
9 Dec 2021to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with cirrhosis

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

31 sites in 1 country.

Xiaolong Qi contact

8618588602600

qixiaolong@vip.163.com

31 sites in 1 country

China31 sites, 31 recruiting

  • The Second Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia

    Tong Dang, MD

    Not yet recruiting

  • Beijing Ditan Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Wen Xie, MD

    Not yet recruiting

  • Bethune First Hospital of Jilin University

    Changchun, Jilin

    Zhongfeng Wang, MD

    Not yet recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan

    Yan Huang, MD

    Not yet recruiting

  • Chongqing Public Health Medical Treatment Center

    Chongqing, Chongqing Municipality

    Xiangbo Chi, MD

    Not yet recruiting

  • MengChao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian

    Yongyi Zeng, MD

    Not yet recruiting

  • Ganzhou City Fifth People's Hospital

    Ganzhou, Jiangxi

    Guanlin Zhou, MD

    Not yet recruiting

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

    Xinhua Luo, MD

    Not yet recruiting

  • The Second Affiliated Hospital of Hainan Medical College

    Haikou, Hainan

    Weizhong Yang, MD

    Not yet recruiting

  • Hangzhou Xixi Hospital

    Hangzhou, Zhejiang

    Shourong Liu, MD

    Not yet recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Shuchen Li, MD

    Not yet recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Yufeng Gao, MD

    Not yet recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    Yanjing Gao, MD

    Recruiting

  • Second People's Hospital of Yunnan Province

    Kunming, Yunnan

    Jia Wei, MD

    Not yet recruiting

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

    Liting Zhang, MD

    Recruiting

  • The Third People's Hospital of Tibet Autonomous Region

    Lhasa, Tibetan

    Xiaosong Yan, MD

    Not yet recruiting

  • Jiangsu People's Hospital

    Nanjing, Jiangsu

    Jun Li, MD

    Not yet recruiting

  • Guangxi Zhuang Autonomous Region People's Hospital

    Nanning, Guangxi

    Guo Zhang, MD

    Not yet recruiting

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

    Shanghai, Shanghai Municipality

    Huixiong Xu, MD

    Not yet recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning

    Yiling Li, MD

    Not yet recruiting

  • Shenzhen Third People's Hospital

    Shenzhen, Guangdong

    Qing He, MD

    Not yet recruiting

  • The Third Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Caiyan Zhao, MD

    Not yet recruiting

  • The Third People's Hospital of Taiyuan

    Taiyuan, Shanxi

    Ying Guo, MD

    Not yet recruiting

  • Tianjin Third Central Hospital

    Tianjin, Tianjin Municipality

    Huiling Xiang, MD

    Not yet recruiting

  • Xinjiang Autonomous Region People's Hospital

    Ürümqi, Xinjiang

    Yongping Zhang, MD

    Not yet recruiting

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

    Wuhan, Hubei

    Xin Zheng, MD

    Not yet recruiting

  • Xi'an Hi-tech Hospital

    Xi'an, Shaanxi

    Ying Song, MD

    Not yet recruiting

  • Xichang People's Hospital

    Xichang, Sichuan

    Huasong Huang, MD

    Not yet recruiting

  • The Fourth People's Hospital of Qinghai Province

    Xining, Qinghai

    Hongmei Zu, MD

    Not yet recruiting

  • Ningxia Medical University General Hospital

    Yinchuan, Ningxia

    Shaoqi Yang, MD

    Not yet recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    Jia Shang, MD

    Not yet recruiting

Other trials in China

About this study

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.

Read the 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.

Being tested
Psychometric hepatic encephalopathy score & Stroop test, Drug therapy
Keywords
Minimal hepatic encephalopathy, Cirrhosis, Psychometric hepatic encephalopathy score
Medical subject headings
Hepatic Encephalopathy, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychometric hepatic encephalopathy score & Stroop testDiagnostic 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 therapyDrug

    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.

Study groups in NCT05140837
Study groupRoleWhat they receive
cross-sectional studyNot described
Receives: Diagnostic Test: Psychometric hepatic encephalopathy score & Stroop test
real-world cohort studyNot described
Receives: Drug: Drug therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. Clinical decompensation and death

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

    Measured: 2 year

  3. 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.

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2021
  2. Study start9 Dec 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05140837
Sponsor's protocol ID
CHESS2106
Status last verified
Apr 2023
First submitted
27 Oct 2021
Last updated
25 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31981519

  • 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.

    PubMed 32029053

  • 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.

    PubMed 30871980

  • 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.

    PubMed 34331848

  • 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.

    PubMed 29892178

  • 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.

    PubMed 25038208

  • 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.

    PubMed 30830722

  • 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.

    PubMed 23946605

  • 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.

    PubMed 31576089

  • 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.

    PubMed 30765944

  • 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.

    PubMed 32618647

  • 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.

    PubMed 29457869

  • 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.

    PubMed 37872092

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatic Encephalopathy and Cirrhosis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaolong Qi (8618588602600, qixiaolong@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychometric hepatic encephalopathy score (PHES) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05140837, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.

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