Using spleen stiffness measurement to predict outcomes in liver disease patients with acute liver injury
Spleen Stiffness Measurement Predicts Short-term Outcomes of Chronic Liver Disease Inpatients With Acute Liver Injury: a Prospective, Observational and Multicentre Study
Nanfang Hospital, Southern Medical University · NCT06173947
This study is testing if measuring spleen stiffness can help predict how patients with chronic liver disease and acute liver injury will do in the short term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 411 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06173947 on ClinicalTrials.gov |
What this trial studies
This observational study utilizes a non-invasive tool called spleen stiffness measurement (SSM) to monitor disease progression in inpatients suffering from chronic liver disease (CLD) and acute liver injury. The goal is to establish an early warning model for acute-on-chronic liver failure (ACLF) and to assess how changes in SSM can impact short-term patient outcomes, including morbidity and mortality over 28 and 90 days. By focusing on the relationship between portal hypertension and liver failure, the study aims to provide valuable insights into managing these serious conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with chronic liver diseases and acute liver injury indicated by elevated bilirubin levels.
Not a fit: Patients with prior liver surgeries, severe extrahepatic diseases, or certain mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier diagnosis and improved management of acute-on-chronic liver failure in patients with chronic liver disease.
How similar studies have performed: Previous studies have shown the utility of spleen stiffness measurement in assessing portal hypertension and predicting complications in cirrhotic patients, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Jinjun Chen, PHD — Nanfang Hospital, Southern Medical University
- Study coordinator: Jinjun Chen, PHD
- Email: chjj@smu.edu.cn
- Phone: 86-18588531001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: End Stage Liver Disease, Jaundice, Liver Dysfunction, Portal Hypertension, Chronic Liver Disease, Spleen Stiffness Measurement, Acute-on-Chronic Liver Failure