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

NCT05100485 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-04-25

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Tianjin Second People's Hospital

    collaborator OTHER
  • The Third People's Hospital of Taiyuan

    collaborator OTHER
  • Ehime University Graduate School of Medicine

    collaborator OTHER
  • Korea University Ansan Hospital

    collaborator OTHER
  • Hyogo Medical University

    collaborator OTHER
  • Zagazing University Faculty of Medicine

    collaborator UNKNOWN
  • Institute of Liver and Biliary Sciences (ILBS)

    collaborator UNKNOWN
  • Changi General Hospital

    collaborator OTHER
  • Ruijin Hospital

    collaborator OTHER
  • Hepatopancreatobiliary Surgery Institute of Gansu Province

    lead OTHER

Principal Investigators

  • Xiaolong Qi, MD · Lanzhou University First Affiliated Hospital

  • Qing Xie, MD · Shanghai Jiao Tong university affiliated Ruijin Hospital

  • Jia Li, MD · Tianjin Second People's Hospital

  • Yu Jun Wong, MD · Changi General Hospital

  • Masashi Hirooka, MD · Ehime University Graduate School of Medicine

  • Hirayuki Enomoto, MD · Hyogo Medical University

  • Tae Hyung Kim, MD · Korea UniversityAnsan Hospital

  • Amr Shaaban Hanafy, MD · Zagazig University

  • Ying Guo, MD · The Third People's Hospital of Taiyuan

  • Shiv Sarin, MD · Institute of Liver and Biliary Sciences (ILBS)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-01-01
Completion
2023-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05100485 on ClinicalTrials.gov