CHESS-SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease (CHESS2102)

Overview

Compensated advanced chronic liver disease (cACLD) was associated with a high rate of variceal bleeding, ascites, and hepatic encephalopathy due to portal hypertension. In these patients, esophagogastroduodenoscopy and hepatic venous pressure gradient were recommended methods to evaluate portal hypertension. However, non-invasive predictors of outcomes to stratify care remains needed. Although the updated EASL guideline has recommended that patients with liver stiffness >20kPa or platelets <150*10^9/L had the high risk of decompensation, the criteria remains to be validated. This international multicenter study aims to develop a novel CHESS-SAVE score to further predict the risk of liver decompensation in cACLD patients.

Full Title of Study: “CHESS-SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease: an International Multicenter Study (CHESS2102)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 16, 2021

Detailed Description

Compensated advanced chronic liver disease (cACLD) was associated with a high rate of variceal bleeding, ascites, and hepatic encephalopathy due to portal hypertension. In these patients, esophagogastroduodenoscopy and hepatic venous pressure gradient were recommended methods to evaluate portal hypertension. However, non-invasive predictors of outcomes to stratify care remains needed. Although the updated EASL guideline has recommended that patients with liver stiffness >20kPa or platelets <150*10^9/L had the high risk of decompensation, the criteria remains to be validated. This international multicenter study initialed and enrolled by Chinese Portal Hypertension Alliance (CHESS) aims to develop a novel CHESS-SAVE score to further predict the risk of liver decompensation in cACLD patients.

Interventions

  • Procedure: Esophagogasrtoduodendoscopy and liver stiffness
    • Time frame between elastography measurement and esophagogastroduodendoscopy is within 6 months.
  • Procedure: hepatic venous pressure gradient
    • A method was used to evaluate portal pressure.

Arms, Groups and Cohorts

  • Training cohort
    • A cohort was used to develop the novel score for predicting liver decompensation
  • Validation cohort
    • A cohort was used to validate the performance of novel score for predicting liver decompensation
  • Exploratory cohort
    • A cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension

Clinical Trial Outcome Measures

Primary Measures

  • Accuracy of the CHESS-SAVE score for predicting liver decompensation
    • Time Frame: 3 years
    • To assess the accuracy of the CHESS-SAVE score to predict liver decompensation in patients with compensated advanced chronic liver disease

Participating in This Clinical Trial

Training and validation cohort Inclusion Criteria:

  • age more than 18 years; – fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis Exclusion Criteria:

  • prior liver decompensation; – 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 Inclusion Criteria:

  • age more than 18 years; – fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis Exclusion Criteria:

  • 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hepatopancreatobiliary Surgery Institute of Gansu Province
  • Collaborator
    • LanZhou University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiaolong Qi, Chief – Hepatopancreatobiliary Surgery Institute of Gansu Province
  • Overall Contact(s)
    • Xiaolong Qi, MD, +8618588602600, qixiaolong@vip.163.com

References

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Villanueva C, Albillos A, Genescà J, Garcia-Pagan JC, Calleja JL, Aracil C, Bañares R, Morillas RM, Poca M, Peñas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J. β 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. Erratum in: Lancet. 2019 Jun 22;393(10190):2492.

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.

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. Review.

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. Erratum in: Hepatology. 2017 Jul;66(1):304-305.

Thabut D, Bureau C, Layese R, Bourcier V, Hammouche M, Cagnot C, Marcellin P, Guyader D, Pol S, Larrey D, De Lédinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Goria O, Calès P, Péron JM, Alric L, Bourlière M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grangé 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.

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