Clinical trial NCT03295812: Stratification of Chronic Alcoholic Liver Diseases (SCALE Study)
Official title: Stratification of Chronic Alcoholic Liver Diseases (SCALE Study) Based on Organs Injury: a Multi-center Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcoholic Liver Disease
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from all in-patients in 24 hepatology departments

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 4-week mortality
timeFrame: 4 weeks
measure: 12-week mortality
timeFrame: 12 weeks
Secondary outcomes:
measure: 4-week progression rate
timeFrame: 4 weeks
measure: 24-week mortality
timeFrame: 24 weeks
measure: 48-week mortality
timeFrame: 48 weeks
Other outcomes:
measure: Risk factors for disease progression within 4 weeks
timeFrame: 4 weeks
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Qingyuan
country: China
facility: People's hospital of Yangshan
state: Guangdong
city: Dongguan
country: China
facility: Dongguan dalang hospital
city: Foshan
country: China
facility: People's hospital of Foshan Nanhai District
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital,Guangzhou University of Chinese Medicine
city: Guangzhou
country: China
facility: The First Affiliated Hospital,Jinan University
city: Huizhou
country: China
facility: Huizhou Central Hospital
city: Huizhou
country: China
facility: Huizhou Hospital of Traditional Chinese Medicine
city: Huizhou
country: China
facility: The First People's Hospital of Huizhou
city: Huizhou
country: China
facility: The Sixth People's Hospital of Huizhou
city: Huizhou
country: China
facility: The Third People's hospital of Huizhou
city: Jiangmen
country: China
facility: People's Hospital of Enping
city: Kaiping
country: China
facility: Kaiping Central Hospital
city: Shaoguan
country: China
facility: The Second People's Hospital of Yuebei
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
city: Shunde
country: China
facility: Shunde Hospital of Southern Medical University
city: Yangjiang
country: China
facility: Yangjiang Public Health Hospital
city: Yingde
country: China
facility: People's Hospital of Yingde City
city: Zhanjiang
country: China
facility: Nongken Central Hospital
city: Zhaoqing
country: China
facility: The First People's Hospital of Zhaoqing
city: Zhaoqing
country: China
facility: Zhaoqing No.2 People's Hospital
city: Zhongshan
country: China
facility: Zhongshan Second People's Hospital
Study officials:
affiliation: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
name: Jinjun Chen
role: PRINCIPAL_INVESTIGATOR
References: