Algorithm to Stratify Clinical Decompensation Risk in Patients With Compensated Advanced Chronic Liver Disease (CHESS2108)
NCT ID: NCT05100485
Last Updated: 2023-04-25
Study Results
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Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2022-01-01
2023-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Training cohort
Training cohort was used to developement the new algorithm for predicting liver decompensation.
Esophagogasrtoduodendoscopy
Esophagogasrtoduodendoscopy was used to detech the presence of varices.
Validation cohort
Validation cohort was used to test the performance of the new algorithm in predicting liver decompensation.
Esophagogasrtoduodendoscopy
Esophagogasrtoduodendoscopy was used to detech the presence of varices.
HVPG cohort
HVPG cohort, a cross-section cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension.
Esophagogasrtoduodendoscopy
Esophagogasrtoduodendoscopy was used to detech the presence of varices.
Hepatic venous pressure gradient
A method used to eveluate the portal pressure
Interventions
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Esophagogasrtoduodendoscopy
Esophagogasrtoduodendoscopy was used to detech the presence of varices.
Hepatic venous pressure gradient
A method used to eveluate the portal pressure
Eligibility Criteria
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Inclusion Criteria
2. fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus.
1. age above or equal to 18-year-old,
2. fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus.
Exclusion Criteria
2. hepatocellular carcinoma,
3. prior liver transplantation,
4. portal vein thrombosis,
5. antiplatelet or anticoagulation,
6. without screening endoscopy within six months of transient elastography,
7. alcoholic cirrhosis with significant ongoing alcohol intake,
8. presence of gastric varix,
9. incomplete follow-up data.
HVPG cohort.
1. prior hepatic decompensation,
2. hepatocellular carcinoma,
3. prior liver transplantation,
4. portal vein thrombosis,
5. antiplatelet or anticoagulation,
6. without screening endoscopy within six months of transient elastography,
7. alcoholic cirrhosis with significant ongoing alcohol intake,
8. presence of gastric varix,
9. non-sinusoidal portal hypertension.
18 Years
ALL
No
Sponsors
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Tianjin Second People's Hospital
OTHER
The Third People's Hospital of Taiyuan
OTHER
Ehime University Graduate School of Medicine
OTHER
Korea University Ansan Hospital
OTHER
Hyogo Medical University
OTHER
Zagazing University Faculty of Medicine
UNKNOWN
Institute of Liver and Biliary Sciences (ILBS)
UNKNOWN
Changi General Hospital
OTHER
Ruijin Hospital
OTHER
Hepatopancreatobiliary Surgery Institute of Gansu Province
OTHER
Responsible Party
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Xiaolong Qi
Prof.
Principal Investigators
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Xiaolong Qi, MD
Role: STUDY_CHAIR
Lanzhou University First Affiliated Hospital
Qing Xie, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong university affiliated Ruijin Hospital
Jia Li, MD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Second People's Hospital
Yu Jun Wong, MD
Role: PRINCIPAL_INVESTIGATOR
Changi General Hospital
Masashi Hirooka, MD
Role: PRINCIPAL_INVESTIGATOR
Ehime University Graduate School of Medicine
Hirayuki Enomoto, MD
Role: PRINCIPAL_INVESTIGATOR
Hyogo Medical University
Tae Hyung Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Korea UniversityAnsan Hospital
Amr Shaaban Hanafy, MD
Role: PRINCIPAL_INVESTIGATOR
Zagazig University
Ying Guo, MD
Role: PRINCIPAL_INVESTIGATOR
The Third People's Hospital of Taiyuan
Shiv Sarin, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Liver and Biliary Sciences (ILBS)
Locations
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Zhongda Hospital
Nanjing, Jiangsu, China
Countries
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References
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Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
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.
Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J. beta blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2019 Apr 20;393(10181):1597-1608. doi: 10.1016/S0140-6736(18)31875-0. Epub 2019 Mar 22.
European Association for the Study of the Liver. EASL Clinical Practice Guidelines on non-invasive tests for evaluation of liver disease severity and prognosis - 2021 update. J Hepatol. 2021 Sep;75(3):659-689. doi: 10.1016/j.jhep.2021.05.025. Epub 2021 Jun 21.
Albilllos A, Garcia-Tsao G. Classification of cirrhosis: the clinical use of HVPG measurements. Dis Markers. 2011;31(3):121-8. doi: 10.3233/DMA-2011-0834.
Ripoll C, Groszmann R, Garcia-Tsao G, Grace N, Burroughs A, Planas R, Escorsell A, Garcia-Pagan JC, Makuch R, Patch D, Matloff DS, Bosch J; Portal Hypertension Collaborative Group. Hepatic venous pressure gradient predicts clinical decompensation in patients with compensated cirrhosis. Gastroenterology. 2007 Aug;133(2):481-8. doi: 10.1053/j.gastro.2007.05.024. Epub 2007 May 21.
Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1.
Thabut D, Bureau C, Layese R, Bourcier V, Hammouche M, Cagnot C, Marcellin P, Guyader D, Pol S, Larrey D, De Ledinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Goria O, Cales P, Peron JM, Alric L, Bourliere M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grange JD, Attali P, Bacq Y, Wartelle-Bladou C, Dao T, Pilette C, Silvain C, Christidis C, Capron D, Bernard-Chabert B, Hillaire S, Di Martino V, Sutton A, Audureau E, Roudot-Thoraval F, Nahon P; ANRS CO12 CirVir group. Validation of Baveno VI Criteria for Screening and Surveillance of Esophageal Varices in Patients With Compensated Cirrhosis and a Sustained Response to Antiviral Therapy. Gastroenterology. 2019 Mar;156(4):997-1009.e5. doi: 10.1053/j.gastro.2018.11.053. Epub 2019 Feb 13.
Abraldes JG, Bureau C, Stefanescu H, Augustin S, Ney M, Blasco H, Procopet B, Bosch J, Genesca J, Berzigotti A; Anticipate Investigators. Noninvasive tools and risk of clinically significant portal hypertension and varices in compensated cirrhosis: The "Anticipate" study. Hepatology. 2016 Dec;64(6):2173-2184. doi: 10.1002/hep.28824. Epub 2016 Oct 27.
Chen RC, Cai YJ, Wu JM, Wang XD, Song M, Wang YQ, Zheng MH, Chen YP, Lin Z, Shi KQ. Usefulness of albumin-bilirubin grade for evaluation of long-term prognosis for hepatitis B-related cirrhosis. J Viral Hepat. 2017 Mar;24(3):238-245. doi: 10.1111/jvh.12638. Epub 2016 Nov 14.
Other Identifiers
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CHESS2108
Identifier Type: -
Identifier Source: org_study_id
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