Stratification of Chronic Alcoholic Liver Diseases (SCALE Study)

Alcoholic Liver Disease Clinical Trial

— SCALE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03295812
• Other study ID #: 004
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2017
• Last updated: January 19, 2018
• Start date: November 16, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jinjun Chen
• Phone: 0086-18588531001
• Email: chjj[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholic Liver Disease
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

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

Locations

Country	Name	City	State
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	Nanfang Hospital	Guangzhou	Guangdong
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	People's hospital of Yangshan	Qingyuan	Guangdong
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

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Risk factors for disease progression within 4 weeks	analysis of risk factors for disease progression	4 weeks
Primary	4-week mortality	mortality rate	4 weeks
Primary	12-week mortality	mortality rate	12 weeks
Secondary	4-week progression rate	The proportion of subjects progressed to acute-on-chronic liver failure within 4 weeks	4 weeks
Secondary	24-week mortality	mortality rate	24 weeks
Secondary	48-week mortality	mortality rate	48 weeks