CHESS-SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease (CHESS2102)
NCT ID: NCT04975477
Last Updated: 2021-07-23
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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UNKNOWN
1000 participants
OBSERVATIONAL
2021-07-16
2021-08-16
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
A cohort was used to develop the novel score for predicting liver decompensation
Esophagogasrtoduodendoscopy and liver stiffness
Time frame between elastography measurement and esophagogastroduodendoscopy is within 6 months.
Validation cohort
A cohort was used to validate the performance of novel score for predicting liver decompensation
Esophagogasrtoduodendoscopy and liver stiffness
Time frame between elastography measurement and esophagogastroduodendoscopy is within 6 months.
Exploratory cohort
A cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension
Esophagogasrtoduodendoscopy and liver stiffness
Time frame between elastography measurement and esophagogastroduodendoscopy is within 6 months.
hepatic venous pressure gradient
A method was used to evaluate portal pressure.
Interventions
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Esophagogasrtoduodendoscopy and liver stiffness
Time frame between elastography measurement and esophagogastroduodendoscopy is within 6 months.
hepatic venous pressure gradient
A method was used to evaluate portal pressure.
Eligibility Criteria
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Inclusion Criteria
* fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis
* age more than 18 years;
* fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis
Exclusion Criteria
* hepatocellular carcinoma;
* prior liver transplantation;
* portal vein thrombosis;
* antiplatelet or anticoagulation;
* without screening EGD within six months of TE;
* incomplete follow-up data.
HVPG cohort
* prior liver decompensation;
* hepatocellular carcinoma;
* prior liver transplantation;
* portal vein thrombosis;
* antiplatelet or anticoagulation;
* without screening EGD within six months of TE;
* without HVPG measurement;
* non-sinusoidal portal hypertension.
18 Years
ALL
No
Sponsors
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LanZhou University
OTHER
Institute of Liver and Biliary Sciences (ILBS)
UNKNOWN
Zagazig University
OTHER_GOV
Korea University
OTHER
Ehime University Graduate School of Medicine
OTHER
Hyogo Medical University
OTHER
Tianjin Second People's Hospital
OTHER
Ruijin Hospital
OTHER
Hepatopancreatobiliary Surgery Institute of Gansu Province
OTHER
Responsible Party
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Xiaolong Qi
Chief
Locations
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Ruijin Hospital
Shanghai, , China
Tianjin Second People's Hospital
Tianjin, , China
Zagazig University Faculty of Medicine
Zagazig, , Egypt
Institute of Liver and Biliary Sciences
New Delhi, , India
Ehime University Graduate School of Medicine
Matsuyama, , Japan
Hyogo College of Medicine
Nishinomiya, , Japan
Korea University Ansan Hospital
Gyeonggi-do, , South Korea
Countries
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Central Contacts
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Facility Contacts
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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.
Sarin SK, Lamba GS, Kumar M, Misra A, Murthy NS. Comparison of endoscopic ligation and propranolol for the primary prevention of variceal bleeding. N Engl J Med. 1999 Apr 1;340(13):988-93. doi: 10.1056/NEJM199904013401302.
Cholongitas E, Papatheodoridis GV, Vangeli M, Terreni N, Patch D, Burroughs AK. Systematic review: The model for end-stage liver disease--should it replace Child-Pugh's classification for assessing prognosis in cirrhosis? Aliment Pharmacol Ther. 2005 Dec;22(11-12):1079-89. doi: 10.1111/j.1365-2036.2005.02691.x.
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.
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.
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.
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.
Liu C, Cao Z, Yan H, Wong YJ, Xie Q, Hirooka M, Enomoto H, Kim TH, Hanafy AS, Liu Y, Huang Y, Li X, Kang N, Koizumi Y, Hiasa Y, Nishimura T, Iijima H, Jung YK, Yim HJ, Guo Y, Zhang L, Ma J, Kumar M, Jindal A, Teh KB, Sarin SK, Qi X. A Novel SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease (CHESS2102): An International Multicenter Cohort Study. Am J Gastroenterol. 2022 Oct 1;117(10):1605-1613. doi: 10.14309/ajg.0000000000001873. Epub 2022 Jun 15.
Other Identifiers
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CHESS2102
Identifier Type: -
Identifier Source: org_study_id
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