Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis
NCT ID: NCT06392503
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2500 participants
OBSERVATIONAL
2023-11-30
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
OTHER
Study Groups
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retrospective cohort group
patients before the study started
different diagnostic models
the patients were screened by different diagnostic models
prospective cohort group
spatients after the study started
different diagnostic models
the patients were screened by different diagnostic models
Interventions
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different diagnostic models
the patients were screened by different diagnostic models
Eligibility Criteria
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Inclusion Criteria
2. Patients with liver cirrhosis diagnosed by clinical or imaging diagnosis;
3. The interval of iLivTouch and esophagogastroduodenoscopy is no more than 3 months;
Exclusion Criteria
2. any decompensation events (ascites, hepatic encephalopathy or gastroesophageal variceal bleeding) during endoscopy or iLivTouch examination, or during the interval between them;
3. currently taking nonselective beta blocker/ antiplatelet / anticoagulant drugs;
4. hepatocellular carcinoma;
5. after transjugular intrahepatic portosystemic shunt surgery;
6. after liver transplantation.
7. portal-spleen-mesenteric venous thrombosis;
8. patients with splenectomy;
9. BMI ≥ 30;
10. patients with acute active hepatitis or patients with cholestatic hepatitis;
11. IQR/median of liver stiffness measurement \> 30%.
18 Years
75 Years
ALL
Yes
Sponsors
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Qianfoshan Hospital
OTHER
First Hospital of China Medical University
OTHER
The Second Affiliated Hospital of Dalian Medical University
OTHER
Second Hospital of Jilin University
OTHER
Shengjing Hospital
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
The First Hospital of Yulin
UNKNOWN
LanZhou University
OTHER
Chengdu Third People's Hospital
UNKNOWN
Tianjin Third Central Hospital
OTHER
Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
People's Hospital of Lixin County
UNKNOWN
The Fourth People's Hospital of Qinghai Province
OTHER
The Fourth People's Hospital of Nanning
OTHER
The Third People's Hospital of Taiyuan
OTHER
Central Hospital of Huludao
UNKNOWN
Jixi Infectious Diseases Hospital
UNKNOWN
the first affiliated hospital of Jiamusi university
UNKNOWN
Benxi Sixth People's Hospital
UNKNOWN
Yuncheng Central Hospital
OTHER
The First People's Hospital of Zigong City, Sichuan Province
UNKNOWN
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Ruikang Affiliated Hospital of Guangxi University of Chinese Medicine
UNKNOWN
Guilin People's Hospital
UNKNOWN
Tianjin Binhai New Area Dagang Hospital
UNKNOWN
Beijing 302 Hospital
OTHER
Responsible Party
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Principal Investigators
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Fu junliang
Role: PRINCIPAL_INVESTIGATOR
the Fifth Medical Center, Chinese PLA General Hospital
Locations
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the Fifth Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Junliang Fu, MD
Role: primary
References
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Yan Y, Xing X, Wang X, Yang L. Liver stiffness by two-dimensional shear wave elastography for screening high-risk varices in patients with compensated advanced chronic liver disease. Eur Radiol. 2022 Mar;32(3):2078-2088. doi: 10.1007/s00330-021-08280-3. Epub 2021 Oct 29.
de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
Augustin S, Pons M, Maurice JB, Bureau C, Stefanescu H, Ney M, Blasco H, Procopet B, Tsochatzis E, Westbrook RH, Bosch J, Berzigotti A, Abraldes JG, Genesca J. Expanding the Baveno VI criteria for the screening of varices in patients with compensated advanced chronic liver disease. Hepatology. 2017 Dec;66(6):1980-1988. doi: 10.1002/hep.29363. Epub 2017 Oct 30.
Wang H, Wen B, Chang X, Wu Q, Wen W, Zhou F, Guo Y, Ji Y, Gu Y, Lai Q, He Q, Li J, Chen J, Hou J. Baveno VI criteria and spleen stiffness measurement rule out high-risk varices in virally suppressed HBV-related cirrhosis. J Hepatol. 2021 Mar;74(3):584-592. doi: 10.1016/j.jhep.2020.09.034. Epub 2020 Oct 8.
de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
Zhang X, Song J, Zhang Y, Wen B, Dai L, Xi R, Wu Q, Li Y, Luo X, Lan X, He Q, Luo W, Lai Q, Ji Y, Zhou L, Qi T, Liu M, Zhou F, Wen W, Li H, Liu Z, Chen Y, Zhu Y, Li J, Huang J, Cheng X, Tu M, Hou J, Wang H, Chen J. Baveno VII algorithm outperformed other models in ruling out high-risk varices in individuals with HBV-related cirrhosis. J Hepatol. 2023 Mar;78(3):574-583. doi: 10.1016/j.jhep.2022.10.030. Epub 2022 Nov 7.
Ng YZ, Lai LL, Wong SW, Mohamad SY, Chuah KH, Chan WK. Attenuation parameter and liver stiffness measurement using FibroTouch vs Fibroscan in patients with chronic liver disease. PLoS One. 2021 May 3;16(5):e0250300. doi: 10.1371/journal.pone.0250300. eCollection 2021.
Ou X, Wang X, Wu X, Kong Y, Duan W, Zhou J, Sun D, Wang Y, You H, Jia J. [Comparison of FibroTouch and FibroScan for the assessment of fibrosis in chronic hepatitis B patients]. Zhonghua Gan Zang Bing Za Zhi. 2015 Feb;23(2):103-6. doi: 10.3760/cma.j.issn.1007-3418.2015.02.006. Chinese.
Zeng J, Sun WL, Chen GY, Pan Q, Yan SY, Sun C, Xu ZJ, Fan JG. [Efficiency of FibroScan and FibroTouch in liver stiffness measurement and fat quantification: a comparative analysis]. Zhonghua Gan Zang Bing Za Zhi. 2016 Sep 20;24(9):652-658. doi: 10.3760/cma.j.issn.1007-3418.2016.09.004. Chinese.
Colecchia A, Ravaioli F, Marasco G, Colli A, Dajti E, Di Biase AR, Bacchi Reggiani ML, Berzigotti A, Pinzani M, Festi D. A combined model based on spleen stiffness measurement and Baveno VI criteria to rule out high-risk varices in advanced chronic liver disease. J Hepatol. 2018 Aug;69(2):308-317. doi: 10.1016/j.jhep.2018.04.023. Epub 2018 May 3.
Other Identifiers
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KY-2023-10-59-1
Identifier Type: -
Identifier Source: org_study_id