Stratification of Chronic Alcoholic Liver Diseases (SCALE Study)

NCT ID: NCT03295812

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-16

Study Completion Date

2020-12-30

Brief Summary

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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

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Conditions

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Alcoholic Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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standard therapy

standard therapy,non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinjun Chen

Role: PRINCIPAL_INVESTIGATOR

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Locations

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Nanfang Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

People's hospital of Yangshan

Qingyuan, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

Dongguan dalang hospital

Dongguan, , China

Site Status ACTIVE_NOT_RECRUITING

People's hospital of Foshan Nanhai District

Foshan, , China

Site Status RECRUITING

The First People's Hospital of Foshan

Foshan, , China

Site Status RECRUITING

Guangdong General Hospital

Guangzhou, , China

Site Status ACTIVE_NOT_RECRUITING

Guangzhou Eighth People's Hospital

Guangzhou, , China

Site Status ACTIVE_NOT_RECRUITING

The First Affiliated Hospital,Guangzhou University of Chinese Medicine

Guangzhou, , China

Site Status ACTIVE_NOT_RECRUITING

The First Affiliated Hospital,Jinan University

Guangzhou, , China

Site Status ACTIVE_NOT_RECRUITING

Huizhou Central Hospital

Huizhou, , China

Site Status RECRUITING

Huizhou Hospital of Traditional Chinese Medicine

Huizhou, , China

Site Status RECRUITING

The First People's Hospital of Huizhou

Huizhou, , China

Site Status RECRUITING

The Sixth People's Hospital of Huizhou

Huizhou, , China

Site Status RECRUITING

The Third People's hospital of Huizhou

Huizhou, , China

Site Status RECRUITING

People's Hospital of Enping

Jiangmen, , China

Site Status NOT_YET_RECRUITING

Kaiping Central Hospital

Kaiping, , China

Site Status ACTIVE_NOT_RECRUITING

The Second People's Hospital of Yuebei

Shaoguan, , China

Site Status ACTIVE_NOT_RECRUITING

Peking University Shenzhen Hospital

Shenzhen, , China

Site Status RECRUITING

Shenzhen Third People's Hospital

Shenzhen, , China

Site Status ACTIVE_NOT_RECRUITING

Shunde Hospital of Southern Medical University

Shunde, , China

Site Status RECRUITING

Yangjiang Public Health Hospital

Yangjiang, , China

Site Status ACTIVE_NOT_RECRUITING

People's Hospital of Yingde City

Yingde, , China

Site Status RECRUITING

Nongken Central Hospital

Zhanjiang, , China

Site Status NOT_YET_RECRUITING

The First People's Hospital of Zhaoqing

Zhaoqing, , China

Site Status ACTIVE_NOT_RECRUITING

Zhaoqing No.2 People's Hospital

Zhaoqing, , China

Site Status ACTIVE_NOT_RECRUITING

Zhongshan Second People's Hospital

Zhongshan, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jinjun Chen

Role: CONTACT

0086-18588531001

Tingting Qi

Role: CONTACT

+8615521287260

Facility Contacts

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Jinjun Chen

Role: primary

+8615521287260

Tingting Qi

Role: backup

+8615521287260

Yan Chen

Role: primary

Role: backup

Lixian Wu

Role: primary

Zhanzhou Lin

Role: primary

Xianhua Huang

Role: primary

Xiaohui Zhang

Role: primary

Gang Li

Role: primary

Xuhui Li

Role: primary

Chongguang Zheng

Role: primary

Jing Wu

Role: primary

Peng Wang

Role: primary

liangmin An

Role: primary

Tengqing Li

Role: primary

Wenjun Gao

Role: primary

Other Identifiers

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004

Identifier Type: -

Identifier Source: org_study_id

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