Stratification of Chronic Alcoholic Liver Diseases (SCALE Study)

Overview

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.

Full Title of Study: “Stratification of Chronic Alcoholic Liver Diseases (SCALE Study) Based on Organs Injury: a Multi-center Prospective Observational Study”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: December 30, 2019

Interventions

• Other: standard therapy
  • standard therapy,non-interventional study

Clinical Trial Outcome Measures

Primary Measures

• 4-week mortality
  • Time Frame: 4 weeks
  • mortality rate
• 12-week mortality
  • Time Frame: 12 weeks
  • mortality rate

Secondary Measures

• 4-week progression rate
  • Time Frame: 4 weeks
  • The proportion of subjects progressed to acute-on-chronic liver failure within 4 weeks
• 24-week mortality
  • Time Frame: 24 weeks
  • mortality rate
• 48-week mortality
  • Time Frame: 48 weeks
  • mortality rate

Participating in This Clinical Trial

Inclusion Criteria

1. Long-term alcohol consumption (at least one of the followings): 1. >40g/d for male and >20g/d for female, at least for 5 years; 2. >50g/d for at least 6 months; 2. Liver injury (at least one of the followings): 1. AST>1.0 ULN and AST>ALT; 2. TBIL>2.0mg/dl; 3. Ascites; 4. Hepatic encephalopathy; 5. Esophageal variceal bleeding; 6. Hypersplenism Exclusion Criteria:

1. Younger than 18 or older than 80; 2. Other etiologies rather than alcoholic liver disease, including but not limited to the followings: 1. Acute or chronic virologic hepatitis: Hepatitis A-E, Hepatitis caused by CMV,EBV, etc. 2. Autoimmune hepatitis, including PSC, PBC, AIH, IgG4 related liver disease 3. Inherited metabolic liver diseases: Wilson disease; 4. Others: Schistosomiasis 3. HIV antibody positive; 4. Malignancies including but not limited to HCC; 5. Pregnancy; 6. Hospital stay less than 24h; 7. Refuse to sigh the informed consent; 8. Combined with other improper situations determined by investigators.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Nanfang Hospital of Southern Medical University
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Jinjun Chen, Principal Investigator, Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
• Overall Contact(s)
  • Jinjun Chen, 0086-18588531001, chjj@smu.edu.cn