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

NCT ID: NCT05100485

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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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 international multicenter cohort study intended to investigate a novel algorithm to stratify the decompensation risk in patients with cACLD.

Conditions

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Compensated Advanced Chronic Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Training cohort

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

Esophagogasrtoduodendoscopy

Intervention Type DIAGNOSTIC_TEST

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.

Esophagogasrtoduodendoscopy

Intervention Type DIAGNOSTIC_TEST

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.

Esophagogasrtoduodendoscopy

Intervention Type DIAGNOSTIC_TEST

Esophagogasrtoduodendoscopy was used to detech the presence of varices.

Hepatic venous pressure gradient

Intervention Type DIAGNOSTIC_TEST

A method used to eveluate the portal pressure

Interventions

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Esophagogasrtoduodendoscopy

Esophagogasrtoduodendoscopy was used to detech the presence of varices.

Intervention Type DIAGNOSTIC_TEST

Hepatic venous pressure gradient

A method used to eveluate the portal pressure

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.


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.


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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Second People's Hospital

OTHER

Sponsor Role collaborator

The Third People's Hospital of Taiyuan

OTHER

Sponsor Role collaborator

Ehime University Graduate School of Medicine

OTHER

Sponsor Role collaborator

Korea University Ansan Hospital

OTHER

Sponsor Role collaborator

Hyogo Medical University

OTHER

Sponsor Role collaborator

Zagazing University Faculty of Medicine

UNKNOWN

Sponsor Role collaborator

Institute of Liver and Biliary Sciences (ILBS)

UNKNOWN

Sponsor Role collaborator

Changi General Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role lead

Responsible Party

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Xiaolong Qi

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaolong Qi, MD

Role: STUDY_CHAIR

Lanzhou University First Affiliated Hospital

Qing Xie, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong university affiliated Ruijin Hospital

Jia Li, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Second People's Hospital

Yu Jun Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital

Masashi Hirooka, MD

Role: PRINCIPAL_INVESTIGATOR

Ehime University Graduate School of Medicine

Hirayuki Enomoto, MD

Role: PRINCIPAL_INVESTIGATOR

Hyogo Medical University

Tae Hyung Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Korea UniversityAnsan Hospital

Amr Shaaban Hanafy, MD

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Ying Guo, MD

Role: PRINCIPAL_INVESTIGATOR

The Third People's Hospital of Taiyuan

Shiv Sarin, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences (ILBS)

Locations

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Zhongda Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 30215362 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26047908 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30910320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34166721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22045397 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17681169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19724251 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30768988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27639071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27862671 (View on PubMed)

Other Identifiers

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CHESS2108

Identifier Type: -

Identifier Source: org_study_id

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