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Recruiting NCT06173947

NCT06173947 SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury

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Clinical Trial Summary
NCT ID NCT06173947
Status Recruiting
Phase
Sponsor Nanfang Hospital, Southern Medical University
Condition End Stage Liver Disease
Study Type OBSERVATIONAL
Enrollment 411 participants
Start Date 2024-01-01
Primary Completion 2025-09-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 80 Years
Study Type OBSERVATIONAL
Interventions
FibroScan® Expert 630

Eligibility Fast-Check

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 411 participants in total. It began in 2024-01-01 with a primary completion date of 2025-09-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Central Contact

Jinjun Chen, PHD

✉ chjj@smu.edu.cn

📞 86-18588531001

Principal Investigator

Jinjun Chen, PHD

PRINCIPAL INVESTIGATOR

Nanfang Hospital, Southern Medical University

Frequently Asked Questions

Who can join the NCT06173947 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying End Stage Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06173947 currently recruiting?

Yes, NCT06173947 is actively recruiting participants. Contact the research team at chjj@smu.edu.cn for enrollment information.

Where is the NCT06173947 trial being conducted?

This trial is being conducted at Guangzhou, China.

Who is sponsoring the NCT06173947 clinical trial?

NCT06173947 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Jinjun Chen, PHD at Nanfang Hospital, Southern Medical University. The trial plans to enroll 411 participants.

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