A Novel Algorithm to Stratify Decompensation Risk in Patients With Compensated Advanced Chronic Liver Disease (CHESS2108): An International, Multicenter Cohort Study
Study Details
Study Description
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,1 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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,1 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Training cohort Training cohort was used to developement the new algorithm for predicting liver decompensation. |
Diagnostic Test: Esophagogasrtoduodendoscopy
Esophagogasrtoduodendoscopy was used to detech the presence of varices.
|
| Validation cohort Validation cohort was used to test the performance of the new algorithm in predicting liver decompensation. |
Diagnostic Test: Esophagogasrtoduodendoscopy
Esophagogasrtoduodendoscopy was used to detech the presence of varices.
|
| 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
Esophagogasrtoduodendoscopy was used to detech the presence of varices.
Diagnostic Test: Hepatic venous pressure gradient
A method used to eveluate the portal pressure
|
Outcome Measures
Primary Outcome Measures
- Accuracy of a novel algorithm for predicting liver decompensation. [3 years]
Aims to investigate the accuracy of the novel algorithm to stratify decompensation risk in patients with cACLD.
Secondary Outcome Measures
- The accuracy of the novel alogrithm for predicting clinically significant portal hypertension. [1 years]
HVPG cohort was used to evaluate the accuracy of the novel alogrithm for predicting clinically significant portal hypertension.
Eligibility Criteria
Criteria
Training and Validation cohort.
Inclusion Criteria:
- (1) age above or equal to 18-year-old, (2) fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus.
Exclusion Criteria:
- (1) prior hepatic decompensation, (2) hepatocellular carcinoma, (3) prior liver transplantation, (4) portal vein thrombosis, (5) antiplatelet or anticoagulation, (6) without screening endoscopy within six months of transient elastography, (7) alcoholic cirrhosis with significant ongoing alcohol intake, (8) presence of gastric varix, (9) incomplete follow-up data.
HVPG cohort.
Inclusion Criteria:
- (1) age above or equal to 18-year-old, (2) fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus.
Exclusion Criteria:
- (1) prior hepatic decompensation, (2) hepatocellular carcinoma, (3) prior liver transplantation, (4) portal vein thrombosis, (5) antiplatelet or anticoagulation, (6) without screening endoscopy within six months of transient elastography, (7) alcoholic cirrhosis with significant ongoing alcohol intake, (8) presence of gastric varix, (9) non-sinusoidal portal hypertension.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Tianjin Second People's Hospital
- Taiyuan third Hospital
- Ehime University Graduate School of Medicine
- Korea University
- Hyogo College of Medicine
- Zagazing University Faculty of Medicine
- Institute of Liver and Biliary Sciences (ILBS)
- Changi General Hospital
- Ruijin Hospital
Investigators
- Study Chair: Xiaolong Qi, MD, Lanzhou University First Affiliated Hospital
- Principal Investigator: 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 College of Medicine
- 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)
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Review.
- Bosch J, Abraldes JG, Berzigotti A, García-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. 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.
- 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.
- European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; Clinical Practice Guideline Panel; Chair:; EASL Governing Board representative:; Panel members:. 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.
- 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.
- 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. Epub 2007 May 21.
- 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.
- 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.
- CHESS2108