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| Name | Class |
|---|---|
| Tianjin Second People's Hospital | OTHER |
| The Third People's Hospital of Taiyuan | OTHER |
| Ehime University Graduate School of Medicine | OTHER |
| Korea University Ansan Hospital |
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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.
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 international multicenter cohort study intended to investigate a novel algorithm to stratify the decompensation risk in patients with cACLD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training cohort | Training cohort was used to developement the new algorithm for predicting liver decompensation. |
| |
| Validation cohort | Validation cohort was used to test the performance of the new algorithm in predicting liver decompensation. |
| |
| HVPG cohort | HVPG cohort, a cross-section cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagogasrtoduodendoscopy | Diagnostic Test | Esophagogasrtoduodendoscopy was used to detech the presence of varices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy of the novel alogrithm for predicting clinically significant portal hypertension. | HVPG cohort was used to evaluate the accuracy of the novel alogrithm for predicting clinically significant portal hypertension. | 1 years |
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Training and Validation cohort
Inclusion Criteria:
Exclusion Criteria:
HVPG cohort.
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30215362 | Background | 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. | |
| 26047908 | 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. |
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| OTHER |
| Hyogo Medical University | OTHER |
| Zagazig University | OTHER_GOV |
| Institute of Liver and Biliary Sciences (ILBS) | UNKNOWN |
| Changi General Hospital | OTHER |
| Ruijin Hospital | OTHER |
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| Hepatic venous pressure gradient | Diagnostic Test | A method used to eveluate the portal pressure |
|
| Shiv Sarin, MD |
| Institute of Liver and Biliary Sciences (ILBS) |
| Principal Investigator |
| 30910320 | 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. |
| 34166721 | 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. |
| 22045397 | 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. |
| 17681169 | 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. |
| 19724251 | 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. |
| 30768988 | 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. |
| 27639071 | 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. |
| 27862671 | 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. |
| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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