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

NCT04975477 | Unknown

• 1 other identifier: CHESS2102
• Study Type: observational
• Target: 1,000
• Locations: 5 countries
• Sites: 7

Brief Summary

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.

Conditions

Compensated Advanced Chronic Liver Disease

Keywords

liver stiffness; platelets; albumin; varices; compensated cirrhosis

Outcome Measures

Primary Outcomes (1)

• Accuracy of the CHESS-SAVE score for predicting liver decompensation

  To assess the accuracy of the CHESS-SAVE score to predict liver decompensation in patients with compensated advanced chronic liver disease

  3 years

Study Arms (3)

Training cohort

A cohort was used to develop the novel score for predicting liver decompensation

Procedure: Esophagogasrtoduodendoscopy and liver stiffness

Validation cohort

A cohort was used to validate the performance of novel score for predicting liver decompensation

Procedure: Esophagogasrtoduodendoscopy and liver stiffness

Exploratory cohort

A cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension

Procedure: Esophagogasrtoduodendoscopy and liver stiffness; Procedure: hepatic venous pressure gradient

Interventions

Esophagogasrtoduodendoscopy and liver stiffness PROCEDURE

Time frame between elastography measurement and esophagogastroduodendoscopy is within 6 months.

Exploratory cohort; Training cohort; Validation cohort

hepatic venous pressure gradient PROCEDURE

A method was used to evaluate portal pressure.

Exploratory cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients were fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis.

You may qualify if:

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

You may not qualify if:

• 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
• age more than 18 years;
• fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis
• prior liver decompensation;
• hepatocellular carcinoma;
• prior liver transplantation;
• portal vein thrombosis;
• antiplatelet or anticoagulation;

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead
• LanZhou University: collaborator
• Institute of Liver and Biliary Sciences (ILBS): collaborator
• Zagazig University: collaborator
• Korea University: collaborator
• Ehime University Graduate School of Medicine: collaborator
• Hyogo Medical University: collaborator
• Tianjin Second People's Hospital: collaborator
• Ruijin Hospital: collaborator

Study Sites (7)

Ruijin Hospital

Shanghai, China

Location

Tianjin Second People's Hospital

Tianjin, China

Location

Zagazig University Faculty of Medicine

Zagazig, Egypt

Location

Institute of Liver and Biliary Sciences

New Delhi, India

Location

Ehime University Graduate School of Medicine

Matsuyama, Japan

Location

Hyogo College of Medicine

Nishinomiya, Japan

Location

Korea University Ansan Hospital

Gyeonggi-do, South Korea

Location

Related Publications (10)

• 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.

  PMID: 30215362 BACKGROUND

• 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.

  PMID: 26047908 BACKGROUND

• 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.

  PMID: 30910320 BACKGROUND

• 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.

  PMID: 10099140 BACKGROUND

• 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.

  PMID: 16305721 BACKGROUND

• 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.

  PMID: 27862671 BACKGROUND

• 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.

  PMID: 27639071 BACKGROUND

• 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.

  PMID: 30768988 BACKGROUND

• 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.

  PMID: 34166721 BACKGROUND

• 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.

  PMID: 35973168 DERIVED

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xiaolong Qi, MD

CONTACT

+8618588602600; qixiaolong@vip.163.com

Chuan Liu, MD

CONTACT

845424585@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: July 16, 2021
• Primary Completion: August 16, 2021
• Study Completion: August 16, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

CN (2); IN (1); JP (2); EG (1); KR (1)