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Completed

NCT Number: NCT05100485

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

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.

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Key information

Conditions

Compensated Advanced Chronic Liver Disease Cardiovascular Diseases Digestive System Diseases Hypertension, Portal Liver Diseases Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda Hospital

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Training and Validation cohort

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • non-sinusoidal portal hypertension.

Treatment and study plan

Esophagogasrtoduodendoscopy

Diagnostic Test

Esophagogasrtoduodendoscopy was used to detech the presence of varices.

Hepatic venous pressure gradient

Diagnostic Test

A method used to eveluate the portal pressure

Primary outcomes

  1. Accuracy of a novel algorithm for predicting liver decompensation.

    Time frame: 3 years

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

Secondary outcomes

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

    Time frame: 1 years

    HVPG cohort was used to evaluate the accuracy of the novel alogrithm for predicting clinically significant portal hypertension.

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Collaborators

  • Changi General Hospital
  • Ehime University Graduate School of Medicine
  • Hyogo Medical University
  • Institute of Liver and Biliary Sciences (ILBS)
  • Korea University Ansan Hospital
  • Ruijin Hospital
  • The Third People's Hospital of Taiyuan
  • Tianjin Second People's Hospital
  • Zagazig University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2021
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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