Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension.
Roberto de Franchis, Baveno VI Faculty
https://pubmed.ncbi.nlm.nih.gov/26047908Actively Recruiting
Age: 18Years - 80Years
All Genders
ID06173947
Spleen Stiffness Measurement Predicts Short-term Outcomes of Chronic Liver Disease Inpatients With Acute Liver Injury: a Prospective, Observational and Multicentre Study
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-05-21
411
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with chronic liver disease (CLD) who have developed acute liver injury. The study aims to use spleen stiffness measurement (SSM), a non-invasive tool, to monitor disease progression and establish an early warning model for acute-on-chronic liver failure (ACLF). This research also investigates how changes in SSM affect short-term outcomes like 28-day and 90-day illness and death rates in these patients. Participants undergo SSM using the FibroScan Expert 630 device, performed first after admission, repeated around day 5, and again before discharge. This observational study tracks changes in spleen stiffness to assess portal hypertension and its relation to liver failure development. The study does not involve experimental treatments but focuses on monitoring through this device. During the study, patients will be monitored for outcomes including 90-day transplant-free mortality, incidence of acute kidney injury, progression to ACLF, and rates of hospital readmission up to 90 days after discharge. Researchers will collect data from these assessments to understand the prognosis better. Participant involvement includes routine clinical monitoring and repeated SSM assessments over their hospital stay and follow-up period, lasting up to 90 days.
CONDITIONS
Brief Title
SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 years and 80 years
- Diagnosis of chronic liver disease regardless of cause
- Acute liver injury with total bilirubin 3 mg/dl or higher regardless of cause
You will not qualify if you...
- Prior liver surgeries such as liver transplantation, TIPS, splenectomy, or partial splenic embolization
- Severe non-liver diseases like advanced chronic obstructive pulmonary disease, end-stage kidney failure, or recent heart attack
- Use of immunosuppressive drugs for reasons other than chronic liver disease
- Diagnosis of liver cancer or other cancers during screening
- Serious mental illnesses including anxiety, depression, OCD, or PTSD
- Pregnancy
- Jaundice caused by bile duct blockage or cholestasis
- Any condition judged by investigators to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - From admission to discharge
Participants undergo spleen stiffness measurement (SSM) with the FibroScan® Expert 630 device to monitor portal hypertension and liver disease progression during hospitalization.
3 visits (at admission, day 5±2, and before discharge)
Long-term Monitoring
Duration - Up to 90 days after discharge
Participants are observed for outcomes such as transplant-free survival, incidence of acute kidney injury, progression to acute-on-chronic liver failure, and hospital readmission for up to 90 days after discharge.
Follow-up assessments up to Day 90
Trial Site Locations
Total: 1 location
1
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Loading map...
Research Team
J
Jinjun Chen, PHD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Baveno VII - Renewing consensus in portal hypertension.
Roberto de Franchis, Jaime Bosch, Guadalupe Garcia-Tsao...
https://pubmed.ncbi.nlm.nih.gov/35120736Acute-on-chronic liver failure is a distinct syndrome that develops in patients with acute decompensation of cirrhosis.
Richard Moreau, Rajiv Jalan, Pere Gines...
https://pubmed.ncbi.nlm.nih.gov/23474284Development of diagnostic criteria and a prognostic score for hepatitis B virus-related acute-on-chronic liver failure.
Tianzhou Wu, Jiang Li, Li Shao...
https://pubmed.ncbi.nlm.nih.gov/28928275Development and validation of a new prognostic score for hepatitis B virus-related acute-on-chronic liver failure.
Jiaqi Li, Xi Liang, Shaoli You...
https://pubmed.ncbi.nlm.nih.gov/34090929Definitions, methodology and therapeutic strategies in portal hypertension. A Consensus Development Workshop, Baveno, Lake Maggiore, Italy, April 5 and 6, 1990.
R de Franchis, J P Pascal, E Ancona...
https://pubmed.ncbi.nlm.nih.gov/1506645Evaluation of portal hypertension in the cirrhotic patient: hepatic vein pressure gradient and beyond.
D S Karagiannakis, T Voulgaris, S I Siakavellas...
https://pubmed.ncbi.nlm.nih.gov/30345856Use of noninvasive markers of portal hypertension and timing of screening endoscopy for gastroesophageal varices in patients with chronic liver disease.
Annalisa Berzigotti, Jaime Bosch, Thomas D Boyer
https://pubmed.ncbi.nlm.nih.gov/23913844Liver stiffness measurement predicts severe portal hypertension in patients with HCV-related cirrhosis.
Francesco Vizzutti, Umberto Arena, Roberto G Romanelli...
https://pubmed.ncbi.nlm.nih.gov/17464971Measurement of spleen stiffness to evaluate portal hypertension and the presence of esophageal varices in patients with HCV-related cirrhosis.
Antonio Colecchia, Lucia Montrone, Eleonora Scaioli...
https://pubmed.ncbi.nlm.nih.gov/22643348