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| Name | Class |
|---|---|
| The Fifth People's Hospital of Suzhou | OTHER |
| Subei People's Hospital of Jiangsu Province | OTHER |
| The Third People's Hospital Of Changzhou | UNKNOWN |
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Purpose Hepatic encephalopathy (HE) is a serious complication of liver cirrhosis that can cause memory loss, slow reaction, and even coma. In China, large-scale epidemiological data on HE are lacking, early diagnosis remains difficult, and treatment needs improvement. This study aims to investigate the prevalence of HE in Chinese liver disease patients and to explore better diagnostic methods and treatment strategies.
Design This is a prospective, multicenter cohort study led by Jiangsu Province Hospital, in collaboration with 7 other hospitals in Jiangsu Province. Between April 2026 and December 2029, the study plans to enroll over 700 patients with liver cirrhosis and 120 healthy volunteers.
What participants will do Participants will use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly. They will be followed up at month 1, 3, 6 after enrollment, and then every six months. The research team will collect routine laboratory results, medication records, and quality-of-life data.
Benefits and risks Participants will receive closer health monitoring, which may help detect changes early. The study involves no additional drugs or invasive procedures, so risks are very low. All personal information will be kept strictly confidential and used only for medical research.
Voluntary participation Participation is completely voluntary, and participants can withdraw at any time without affecting their routine medical care.
Hepatic encephalopathy is a common and serious complication of liver cirrhosis, which greatly affects the quality of life and survival prognosis of patients and imposes a heavy burden on the medical and health system. Among patients with liver cirrhosis, the prevalence of overt hepatic encephalopathy is 10-14%, rising to 16-21% in decompensated liver cirrhosis patients, and reaching 10-50% in those who have undergone transjugular intrahepatic portosystemic shunt (TIPS). The prevalence of minimal hepatic encephalopathy (mHE) ranges from 20% to 80%. Currently, the diagnosis of hepatic encephalopathy still relies on exclusion, and the first-line treatments are lactulose and rifaximin. In summary, there are many patients with hepatic encephalopathy, diagnosis is difficult, and the treatment effect is also limited. Studying the specific conditions of Chinese patients, improving diagnostic methods, and exploring more precise treatment plans are of great significance for improving the quality of life of patients and reducing the medical burden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-CHE | Patients who did not develop covert hepatic encephalopathy during the follow-up period |
| |
| CHE | Patients who develop covert hepatic encephalopathy during the follow-up period |
| |
| liver cirrhosis with sarcopenia | Patients who develop sarcopenia during the follow-up period | ||
| liver cirrhosis without sarcopenia | Patients who did not develop sarcopenia during the follow-up period | ||
| liver cirrhosis with decline in quality of life | During the follow-up period, there was a decline in quality of life. | ||
| liver cirrhosis without decline in quality of life | During the follow-up period, there was not a decline in quality of life. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wechat mini-program | Behavioral | use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| covert hepatic encephalopathy | Patients classified as level 0-1 according to the West Haven classification. The West Haven classification system for hepatic encephalopathy, formally titled the West Haven Classification for Hepatic Encephalopathy, is a semi-quantitative grading system widely used in clinical practice and research to assess the severity of hepatic encephalopathy in patients with cirrhosis. The evaluation is based on a comprehensive clinical assessment of four domains: level of consciousness, intellectual and behavioural function (including orientation, personality, mood, and attention), neuromuscular function (including asterixis, tendon reflexes, and ataxia), and ability to perform activities of daily living. Using these criteria, hepatic encephalopathy is classified into grades ranging from a minimum of Grade 0 to a maximum of Grade 4. | from the time of enrollment until the end of the 2-year follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| Sarcopenia | Sarcopenia refers to the loss of muscle mass. The definition is based on the L3-SMI. | From enrollment to the end of treatment at 2 years |
| decline in quality of life | Evaluated through the SF-36(36-Item Short-Form Health Survey) scale. The SF-36 assesses nine health dimensions. For every dimension (after standard transformation), the minimum possible score is 0 and the maximum possible score is 100. A higher score always indicates a better health outcome or better quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| DEATH | The patient died. | From enrollment to the end of treatment at 2 years |
| liver transplantation | From enrollment to the end of treatment at 2 years |
Inclusion Criteria:
Exclusion Criteria:
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People with liver cirrhosis are diagnosed by doctors through imaging, elastography, biopsy or clinical symptoms.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanlong Zhu | Contact | +8617714316539 | zhuchuanlong@jsph.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38349709 | Result | Ehrenbauer AF, Egge JFM, Gabriel MM, Tiede A, Dirks M, Witt J, Wedemeyer H, Maasoumy B, Weissenborn K. Comparison of 6 tests for diagnosing minimal hepatic encephalopathy and predicting clinical outcome: A prospective, observational study. Hepatology. 2024 Aug 1;80(2):389-402. doi: 10.1097/HEP.0000000000000770. Epub 2024 Feb 13. | |
| 39015557 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2026 | May 16, 2026 |
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| The Third People's Hospital of Zhen jiang |
| UNKNOWN |
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| From enrollment to the end of treatment at 2 years |
| TIPS | From enrollment to the end of treatment at 2 years |
| Li X, Liu S, Guo Y, Zu H, Xiang H, Yang S, Zhang X, Meng F, Bianba Y, Li J, Liu F, Lei C, Lv J, Yang QH, Fu W, Ye W, Chen J, Gao Y, Wu C, Wang N, Zheng Q, Wang F, Yu J, Wang J, Yang X, Wang X, Liu Y, Zhao X, Wu C, Gou W, Bajaj JS, Wang FS, Fu J, Qi X. Detection of minimal hepatic encephalopathy in patients with cirrhosis based on the Stroop-CN model (NCRCID-CHESS 2106): a prospective multicenter study. MedComm (2020). 2024 Jul 15;5(8):e627. doi: 10.1002/mco2.627. eCollection 2024 Aug. |
| 38108656 | Result | Wang J, Deng MJ, Shi PM, Peng Y, Wang XH, Tan W, Wang PQ, Chen YX, Yuan ZL, Ning BF, Xie WF, Yin C. Covert hepatic encephalopathy is associated with aggressive disease progression and poor survival in patients with cirrhosis. J Dig Dis. 2023 Dec;24(12):681-690. doi: 10.1111/1751-2980.13246. |
| 26644276 | Result | Allampati S, Duarte-Rojo A, Thacker LR, Patidar KR, White MB, Klair JS, John B, Heuman DM, Wade JB, Flud C, O'Shea R, Gavis EA, Unser AB, Bajaj JS. Diagnosis of Minimal Hepatic Encephalopathy Using Stroop EncephalApp: A Multicenter US-Based, Norm-Based Study. Am J Gastroenterol. 2016 Jan;111(1):78-86. doi: 10.1038/ajg.2015.377. Epub 2015 Dec 8. |
| 31701074 | Result | Tapper EB, Henderson JB, Parikh ND, Ioannou GN, Lok AS. Incidence of and Risk Factors for Hepatic Encephalopathy in a Population-Based Cohort of Americans With Cirrhosis. Hepatol Commun. 2019 Sep 6;3(11):1510-1519. doi: 10.1002/hep4.1425. eCollection 2019 Nov. |
| 34233031 | Result | Lai JC, Tandon P, Bernal W, Tapper EB, Ekong U, Dasarathy S, Carey EJ. Malnutrition, Frailty, and Sarcopenia in Patients With Cirrhosis: 2021 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021 Sep;74(3):1611-1644. doi: 10.1002/hep.32049. No abstract available. |
| 41773757 | Result | Bajaj JS, Jakab SS, Jesudian AB, Rahimi RS, Duarte-Rojo A, Chen PH, Wong RJ, Tapper EB, Tandon P. ACG Clinical Guideline: Hepatic Encephalopathy. Am J Gastroenterol. 2026 Mar 1;121(3):588-618. doi: 10.14309/ajg.0000000000003899. Epub 2026 Mar 3. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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