A Prospective Cohort Study on the Epidemiological Investigation, Diagnosis, and Treatment of Hepatic Encephalopathy
2026년 7월 14일 업데이트: Chuanlong Zhu, The First Affiliated Hospital with Nanjing Medical University
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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (추정된)
700
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Chuanlong Zhu
- 전화번호: +8617714316539
- 이메일: zhuchuanlong@jsph.org.cn
연구 장소
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Jiangsu
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Nanjing, Jiangsu, 중국
- Jiangsu Province Hospital
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연락하다:
- Chuanlong Zhu
- 전화번호: +8617714316539
- 이메일: zhuchuanlong@jsph.org.cn
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
People with liver cirrhosis are diagnosed by doctors through imaging, elastography, biopsy or clinical symptoms.
설명
Inclusion Criteria:
- For patients with liver cirrhosis and the general healthy population, the diagnosis of liver cirrhosis is made by doctors based on imaging, elastography, biopsy or clinical symptoms.
- The patients themselves and their accompanying family members have smart phones, are proficient in using WeChat and mini-programs, and have a stable network environment.
- They voluntarily sign the informed consent form, have good compliance, and fully understand this study.
Exclusion Criteria:
- Age < 18 years old;
- Women planning to get pregnant, already pregnant or during lactation;
- Incomplete relevant data information required;
- Unable to proficiently use WeChat mini-program or unstable network environment;
- Red-green color blindness or other irreparable visual impairments;
- Heart, lung, or kidney failure or unstable vital signs;
- Unwilling to participate in the study or unable to sign the informed consent form;
- Any other situation that may interfere with the study assessment, increase the risk for the subjects, or affect their completion of the study, as judged by the researcher and deemed unsuitable for participating in this study;
- Have participated in or are currently participating in other clinical trials within the past 3 months;
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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non-CHE
Patients who did not develop covert hepatic encephalopathy during the follow-up period
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use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly
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CHE
Patients who develop covert hepatic encephalopathy during the follow-up period
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use a WeChat mini-program to perform simple cognitive tests (e.g., reaction speed, attention) regularly
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liver cirrhosis with sarcopenia
Patients who develop sarcopenia during the follow-up period
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liver cirrhosis without sarcopenia
Patients who did not develop sarcopenia during the follow-up period
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liver cirrhosis with decline in quality of life
During the follow-up period, there was a decline in quality of life.
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liver cirrhosis without decline in quality of life
During the follow-up period, there was not a decline in quality of life.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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covert hepatic encephalopathy
기간: from the time of enrollment until the end of the 2-year follow-up period
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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.
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from the time of enrollment until the end of the 2-year follow-up period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sarcopenia
기간: From enrollment to the end of treatment at 2 years
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Sarcopenia refers to the loss of muscle mass.
The definition is based on the L3-SMI.
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From enrollment to the end of treatment at 2 years
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decline in quality of life
기간: From enrollment to the end of treatment at 2 years
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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.
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From enrollment to the end of treatment at 2 years
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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DEATH
기간: From enrollment to the end of treatment at 2 years
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The patient died.
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From enrollment to the end of treatment at 2 years
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liver transplantation
기간: From enrollment to the end of treatment at 2 years
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From enrollment to the end of treatment at 2 years
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TIPS
기간: From enrollment to the end of treatment at 2 years
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From enrollment to the end of treatment at 2 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2028년 1월 31일
연구 완료 (추정된)
2028년 3월 31일
연구 등록 날짜
최초 제출
2026년 5월 16일
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2026년 5월 24일
처음 게시됨 (실제)
2026년 5월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 14일
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2026년 5월 1일
추가 정보
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