Algorithm to Stratify Clinical Decompensation Risk in Patients With Compensated Advanced Chronic Liver Disease (CHESS2108)

NCT05100485 | Completed

• 1 other identifier: CHESS2108
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Compensated advanced chronic liver disease (cACLD) commonly indicates severe fibrosis and compensated cirrhosis at risk of developing clinically significant portal hypertension (CSPH) and hepatic decompensation. The presence of CSPH (defined as hepatic venous pressure gradient \[HVPG\] ≥ 10 mmHg) is the strongest predictor of hepatic decompensation. However, HVPG measurement is invasive, operator dependent, and not widely available. According to the 2021 updated EASL Clinical Practice Guidelines, cACLD patients who did not meet the Baveno VI criteria but had any of the two variables (LSM \> 20 kPa or PLT \< 150 × 109/L) were suggested to perform screening endoscopy and HVPG measurement. However, the number of cACLD patients with unfavorable Baveno VI status is huge, no detailed risk stratifications existed at this timepoint. This study intended to investigate a novel algorithm to stratify the decompensation risk in patients with cACLD.

Conditions

Compensated Advanced Chronic Liver Disease

Keywords

liver stiffness; platelets; portal hypertension; varices; compensated advanced chronic liver disease

Outcome Measures

Primary Outcomes (1)

• Accuracy of a novel algorithm for predicting liver decompensation.

  Aims to investigate the accuracy of the novel algorithm to stratify decompensation risk in patients with cACLD.

  3 years

Secondary Outcomes (1)

• The accuracy of the novel alogrithm for predicting clinically significant portal hypertension.

  1 years

Study Arms (3)

Training cohort

Training cohort was used to developement the new algorithm for predicting liver decompensation.

Diagnostic Test: Esophagogasrtoduodendoscopy

Validation cohort

Validation cohort was used to test the performance of the new algorithm in predicting liver decompensation.

Diagnostic Test: Esophagogasrtoduodendoscopy

HVPG cohort

HVPG cohort, a cross-section cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension.

Diagnostic Test: Esophagogasrtoduodendoscopy; Diagnostic Test: Hepatic venous pressure gradient

Interventions

Esophagogasrtoduodendoscopy DIAGNOSTIC_TEST

Esophagogasrtoduodendoscopy was used to detech the presence of varices.

HVPG cohort; Training cohort; Validation cohort

Hepatic venous pressure gradient DIAGNOSTIC_TEST

A method used to eveluate the portal pressure

HVPG 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

This is an international, multicenter cohort study initialed by Portal Hypertension Alliance in China (CHESS) and eligible patients will enroll from China, Japan, Southern Korea, Egypt, Singapore, and India.

You may qualify if:

• age above or equal to 18-year-old,
• fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus.

You may not qualify if:

• prior hepatic decompensation,
• hepatocellular carcinoma,
• prior liver transplantation,
• portal vein thrombosis,
• antiplatelet or anticoagulation,
• without screening endoscopy within six months of transient elastography,
• alcoholic cirrhosis with significant ongoing alcohol intake,
• presence of gastric varix,
• incomplete follow-up data.
• HVPG cohort.
• age above or equal to 18-year-old,
• fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus.
• prior hepatic decompensation,
• hepatocellular carcinoma,
• prior liver transplantation,

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead
• Tianjin Second People's Hospital: collaborator
• The Third People's Hospital of Taiyuan: collaborator
• Ehime University Graduate School of Medicine: collaborator
• Korea University Ansan Hospital: collaborator
• Hyogo Medical University: collaborator
• Zagazing University Faculty of Medicine: collaborator
• Institute of Liver and Biliary Sciences (ILBS): collaborator
• Changi General Hospital: collaborator
• Ruijin Hospital: collaborator

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210000, China

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

• 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

• 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.

  PMID: 22045397 BACKGROUND

• 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.

  PMID: 17681169 BACKGROUND

• 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.

  PMID: 19724251 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

• 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

• 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

MeSH Terms

Conditions

Hypertension, Portal; Varicose Veins

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xiaolong Qi, MD

  Lanzhou University First Affiliated Hospital

  STUDY CHAIR

• Qing Xie, MD

  Shanghai Jiao Tong university affiliated Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Jia Li, MD

  Tianjin Second People's Hospital

  PRINCIPAL INVESTIGATOR

• Yu Jun Wong, MD

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

• Masashi Hirooka, MD

  Ehime University Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

• Hirayuki Enomoto, MD

  Hyogo Medical University

  PRINCIPAL INVESTIGATOR

• Tae Hyung Kim, MD

  Korea UniversityAnsan Hospital

  PRINCIPAL INVESTIGATOR

• Amr Shaaban Hanafy, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

• Ying Guo, MD

  The Third People's Hospital of Taiyuan

  PRINCIPAL INVESTIGATOR

• Shiv Sarin, MD

  Institute of Liver and Biliary Sciences (ILBS)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 29, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (1)