Stratification of Chronic Alcoholic Liver Diseases (SCALE Study)

• Conditions: Alcoholic Liver Disease

• Registration Number: NCT03295812
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-28
• Study Start: 2017-11-16
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23
• Primary Completion: 2019-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
4-week mortality	4 weeks	mortality rate
12-week mortality	12 weeks	mortality rate

Secondary Outcome Measures

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

Trial Locations

Locations (26)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

People's hospital of Yangshan; 🇨🇳 Qingyuan, Guangdong, China

Dongguan dalang hospital; 🇨🇳 Dongguan, China

People's hospital of Foshan Nanhai District; 🇨🇳 Foshan, China

The First People's Hospital of Foshan; 🇨🇳 Foshan, China

Guangdong General Hospital; 🇨🇳 Guangzhou, China

Guangzhou Eighth People's Hospital; 🇨🇳 Guangzhou, China

The First Affiliated Hospital,Guangzhou University of Chinese Medicine; 🇨🇳 Guangzhou, China

The First Affiliated Hospital,Jinan University; 🇨🇳 Guangzhou, China

Huizhou Central Hospital; 🇨🇳 Huizhou, China

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