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

Compensated Advanced Chronic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04975477
• Other study ID #: CHESS2102
• Status: Not yet recruiting
• Start date: July 16, 2021
• Est. completion date: August 16, 2021

Study information

• Verified date: July 2021
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: Xiaolong Qi, MD
• Phone: +8618588602600
• Email: qixiaolong[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: August 16, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Compensated Advanced Chronic Liver Disease
• Liver Diseases

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai
China	Tianjin Second People's Hospital	Tianjin
Egypt	Zagazig University Faculty of Medicine	Zagazig
India	Institute of Liver and Biliary Sciences	New Delhi
Japan	Ehime University Graduate School of Medicine	Matsuyama
Japan	Hyogo College of Medicine	Nishinomiya
Korea, Republic of	Korea University Ansan Hospital	Gyeonggi-do

Sponsors (9)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province	Ehime University Graduate School of Medicine, Hyogo College of Medicine, Institute of Liver and Biliary Sciences (ILBS), Korea University, LanZhou University, Ruijin Hospital, Tianjin Second People's Hospital, Zagazig University

Countries where clinical trial is conducted

China,  Egypt,  India,  Japan,  Korea, Republic of, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

European Association for the Study of the Liver; List of panel members (alphabetical order), Berzigotti A, Boursier J, Castera L, Cazzagon N, Friedrich-Rust M, Petta S, Thiele M, Tsochatzis E. Easl Clinical Practice Guidelines (Cpgs) On Non-Invasive Tests For Evaluation Of Liver Disease Severity And Prognosis- 2020 Update. J Hepatol. 2021 Jun 3. pii: S0168-8278(21)00398-6. doi: 10.1016/j.jhep.2021.05.025. [Epub ahead of print] — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. ß 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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