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Stratification of Chronic Alcoholic Liver Diseases (SCALE Study)

NCT03295812 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2018-01-23

No results posted yet for this study

Summary

Recent years, the European Association for the Study of the Liver-chronic liver failure (EASL-CLIF) has defined and graded acute-on-chronic liver failure (ACLF) based on CANONIC study which enrolled cirrhotic patients with acute decompensation. However, the characteristics and definitions of ACLF in non-cirrhotic patients with acute deterioration of liver function and organs injury or failure remain to be clear. As for patients who don't fulfil ACLF criteria, there might be a subgroup with high risk of progression (\>25%) and a moderate 4-week mortality rate (\>7%), which can be defined as "pre-ACLF", while the others are just chronic liver disease with "mere" liver injury or decompensation. This stratification system was primarily verified in a previous retrospective cohort which enrolled Hepatitis B patients only. The stratification criteria for chronic alcoholic liver disease needs to be further defined in detail. Therefore, investigators plan to prospectively recruit 3000 chronic alcoholic hospitalized patients with liver dysfunction from 24 hepatology departments in China, aiming to propose a stratified diagnostic system for chronic alcoholic patients based on organs injury. Meanwhile, risk factors of disease progression and short-term mortality will be analyzed, while characteristics and prognosis will be compared between patients with and without cirrhosis.

Conditions

Interventions

OTHER

standard therapy

standard therapy,non-interventional study

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Jinjun Chen · Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-16
Primary Completion
2019-12-30
Completion
2020-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03295812 on ClinicalTrials.gov