Stratification of Chronic Alcoholic Liver Diseases (SCALE Study) (SCALE)

January 19, 2018 updated by: Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Dongguan, China
        • Active, not recruiting
        • Dongguan dalang hospital
      • Foshan, China
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
      • Foshan, China
      • Guangzhou, China
        • Active, not recruiting
        • Guangdong General Hospital
      • Guangzhou, China
        • Active, not recruiting
        • Guangzhou Eighth People's Hospital
      • Guangzhou, China
        • Active, not recruiting
        • The First Affiliated Hospital,Guangzhou University of Chinese Medicine
      • Guangzhou, China
        • Active, not recruiting
        • The First Affiliated Hospital,Jinan University
      • Huizhou, China
      • Huizhou, China
        • Recruiting
        • Huizhou Hospital of Traditional Chinese Medicine
        • Contact:
      • Huizhou, China
      • Huizhou, China
        • Recruiting
        • The Sixth People's Hospital of Huizhou
        • Contact:
      • Huizhou, China
        • Recruiting
        • The Third People's Hospital of Huizhou
        • Contact:
      • Jiangmen, China
        • Not yet recruiting
        • People's Hospital of Enping
        • Contact:
      • Kaiping, China
        • Active, not recruiting
        • Kaiping Central Hospital
      • Shaoguan, China
        • Active, not recruiting
        • The Second People's Hospital of Yuebei
      • Shenzhen, China
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:
      • Shenzhen, China
        • Active, not recruiting
        • Shenzhen Third People's Hospital
      • Shunde, China
        • Recruiting
        • Shunde Hospital of Southern Medical University
        • Contact:
      • Yangjiang, China
        • Active, not recruiting
        • Yangjiang Public Health Hospital
      • Yingde, China
        • Recruiting
        • People's Hospital of Yingde City
        • Contact:
      • Zhanjiang, China
      • Zhaoqing, China
        • Active, not recruiting
        • The First People's Hospital of Zhaoqing
      • Zhaoqing, China
        • Active, not recruiting
        • Zhaoqing No.2 People's Hospital
      • Zhongshan, China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital
      • Qingyuan, Guangdong, China
        • Active, not recruiting
        • People's hospital of Yangshan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be selected from all in-patients in 24 hepatology departments

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4-week mortality
Time Frame: 4 weeks
mortality rate
4 weeks
12-week mortality
Time Frame: 12 weeks
mortality rate
12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for disease progression within 4 weeks
Time Frame: 4 weeks
analysis of risk factors for disease progression
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Jinjun Chen, Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2017

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

September 25, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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