Stratification of Chronic Alcoholic Liver Diseases (SCALE Study)
SCALE
1 other identifier
observational
3,000
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2017
CompletedFirst Posted
Study publicly available on registry
September 28, 2017
CompletedStudy Start
First participant enrolled
November 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedJanuary 23, 2018
September 1, 2017
2.1 years
September 25, 2017
January 19, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
4-week mortality
mortality rate
4 weeks
12-week mortality
mortality rate
12 weeks
Secondary Outcomes (3)
4-week progression rate
4 weeks
24-week mortality
24 weeks
48-week mortality
48 weeks
Other Outcomes (1)
Risk factors for disease progression within 4 weeks
4 weeks
Interventions
standard therapy,non-interventional study
Eligibility Criteria
Patients will be selected from all in-patients in 24 hepatology departments
You may qualify if:
- Long-term alcohol consumption (at least one of the followings):
- \>40g/d for male and \>20g/d for female, at least for 5 years;
- \>50g/d for at least 6 months;
- Liver injury (at least one of the followings):
- AST\>1.0 ULN and AST\>ALT;
- TBIL\>2.0mg/dl;
- Ascites;
- Hepatic encephalopathy;
- Esophageal variceal bleeding;
- Hypersplenism
You may not qualify if:
- Younger than 18 or older than 80;
- Other etiologies rather than alcoholic liver disease, including but not limited to the followings:
- Acute or chronic virologic hepatitis: Hepatitis A-E, Hepatitis caused by CMV,EBV, etc.
- Autoimmune hepatitis, including PSC, PBC, AIH, IgG4 related liver disease
- Inherited metabolic liver diseases: Wilson disease;
- Others: Schistosomiasis
- HIV antibody positive;
- Malignancies including but not limited to HCC;
- Pregnancy;
- Hospital stay less than 24h;
- Refuse to sigh the informed consent;
- Combined with other improper situations determined by investigators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Nanfang Hospital
Guangzhou, Guangdong, 510515, 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
Huizhou Hospital of Traditional Chinese Medicine
Huizhou, China
The First People's Hospital of Huizhou
Huizhou, China
The Sixth People's Hospital of Huizhou
Huizhou, China
The Third People's hospital of Huizhou
Huizhou, China
People's Hospital of Enping
Jiangmen, China
Kaiping Central Hospital
Kaiping, China
The Second People's Hospital of Yuebei
Shaoguan, China
Peking University Shenzhen Hospital
Shenzhen, China
Shenzhen Third People's Hospital
Shenzhen, China
Shunde Hospital of Southern Medical University
Shunde, China
Yangjiang Public Health Hospital
Yangjiang, China
People's Hospital of Yingde City
Yingde, China
Nongken Central Hospital
Zhanjiang, China
The First People's Hospital of Zhaoqing
Zhaoqing, China
Zhaoqing No.2 People's Hospital
Zhaoqing, China
Zhongshan Second People's Hospital
Zhongshan, China
Biospecimen
Plasma, serum, urine and DNA samples will be reserved
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinjun Chen
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2017
First Posted
September 28, 2017
Study Start
November 16, 2017
Primary Completion
December 30, 2019
Study Completion
December 30, 2020
Last Updated
January 23, 2018
Record last verified: 2017-09