SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury

NCT ID: NCT06173947

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 411 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-30

Brief Summary

In this study, a single non-invasive tool, spleen stiffness measurement (SSM), was used to monitor the disease regression of inpatients with chronic liver disease (CLD) and acute liver injury. The present study aimed to establish an early diagnosis warning model for acute-on-chronic liver failure (ACLF) by SSM and investigate the effect of dynamic changes in SSM on the short-term prognosis (28-day, 90-day morbidity and mortality) of inpatients with CLD and acute liver injury.

Detailed Description

Portal hypertension is a major complication of cirrhosis and can lead to serious clinical manifestations such as ascites, hepatic encephalopathy, variceal bleeding, etc. Colecchia et al. proposed the use of spleen stiffness measurement (SSM) to dynamically monitor portal pressure and to predict the risk of oesophageal varices. Studies have now demonstrated the utility of SSM in assessing portal hypertension, ruling out high-risk varices, and predicting clinical complications in cirrhotic patients. Furthermore, the Baveno VII consensus of portal hypertension has included SSM in its recommendations for non-invasive screening. Pathogenic triggers, important clinical events (ascites, encephalopathy, etc.), and short-term prognosis in compensated advanced chronic liver disease are associated with portal pressure. Exploring the relationship between portal hypertension and liver failure development would be of great clinical and scientific value. The present study is mainly based on a single non-invasive tool, SSM, to monitor the disease regression of chronic liver disease (CLD) inpatients with acute liver injury, to establish an early warning model for early diagnosis of acute-on-chronic liver failure, and to investigate the effect of dynamic changes in SSM on the short-term prognosis of inpatients with CLD and acute liver injury.

Conditions

End Stage Liver Disease; Jaundice; Liver Dysfunction; Portal Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

FibroScan® Expert 630

The SSM by FibroScan 630 was first performed after admission, repeated at the day 5±2 as soon as feasible, and finally evaluated before discharge.

Intervention Type: DEVICE

Other Intervention Names

FibroScan® (FibroScan® expert 630 machine; Echosens, Paris, France); Spleen mode (SSM@100 Hz); Spleen vibration-controlled transient elastography (VCTE) settings (SSM@100 Hz); Spleen-dedicated examination based on VCTE (SSM@100 Hz)

Eligibility Criteria

Inclusion Criteria

1. Age between 18 years and 80 years

2. Chronic liver diseases regardless of etiology

3. Acute liver injury with total bilirubin ≥ 3 mg/dl regardless of inducement

Exclusion Criteria

1. Prior surgery of liver diseases before enrollment such as liver transplantation, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy and partial splenic embolization

2. Severe extrahepatic diseases such as chronic obstructive pulmonary disease level IV, chronic kidney disease with end-stage renal failure, myocardial infarction within 3 months before admission

3. Receiving Immunosuppressive drugs for reasons rather than chronic liver diseases

4. Diagnosis of hepatocellular carcinoma or other non-liver malignancies during screening period

5. Serious mental illnesses such as anxiety, depressive disorders to obsessive-compulsive disorder (OCD) and post-traumatic stress disorder (PTSD)

6. The pregnant

7. Jaundice due to biliary obstruction or cholestasis

8. Unsuitable to participate in this study judging by investigators

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinjun Chen, PHD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

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

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinjun Chen, PHD

Role: CONTACT

chjj@smu.edu.cn

86-18588531001

Facility Contacts

Jinjun Chen, PHD

Role: primary

chjj@smu.edu.cn

86-18588531001

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Other Identifiers

NFEC-2023-495

Identifier Type: -

Identifier Source: org_study_id