NCT05140837|UnknownDMC
Loading search results
Sponsor study identifier
observational
10,000
1 country
31
Study Start
December 9, 2021
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 27, 2021
Actual (reported)December 1, 2021
Actual (reported)December 9, 2021
Actual (reported)December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
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.
Patients with cirrhosis
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chongqing Public Health Medical Treatment Center
Chongqing, Chongqing Municipality, China
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.
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.
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
First Submitted
October 27, 2021
First Posted
December 1, 2021
Study Start
December 9, 2021
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)FMT in Cirrhosis and Hepatic Encephalopathy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
MengChao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Shenzhen Third People's Hospital
Shenzhen, Guangdong, China
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
The Second Affiliated Hospital of Hainan Medical College
Haikou, Hainan, China
The Third Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
Jiangsu People's Hospital
Nanjing, Jiangsu, China
Ganzhou City Fifth People's Hospital
Ganzhou, Jiangxi, China
Bethune First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Ningxia Medical University General Hospital
Yinchuan, Ningxia, China
The Fourth People's Hospital of Qinghai Province
Xining, Qinghai, China
Xi'an Hi-tech Hospital
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
The 10th People's Hospital affiliated to Tongji University
Shanghai, Shanghai Municipality, China
The Third People's Hospital of Taiyuan
Taiyuan, Shanxi, China
Xichang People's Hospital
Xichang, Sichuan, China
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, China
The Third People's Hospital of Tibet Autonomous Region
Lhasa, Tibetan, China
Xinjiang Autonomous Region People's Hospital
Ürümqi, Xinjiang, China
Second People's Hospital of Yunnan Province
Kunming, Yunnan, China
Hangzhou Xixi Hospital
Hangzhou, Zhejiang, China
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 25, 2023
Record last verified: 2023-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: