About this trial
The goal of this observational study is to learn if spleen stiffness and other non-invasive markers can help predict recompensation in people with decompensated cirrhosis who are receiving effective treatment for the cause of their liver disease. The main questions it aims to answer are:
* Can spleen stiffness and blood test results predict who will get better and stay better after cirrhosis becomes worse? * What are the features of people who recover after decompensation?
Participants will:
* Be people with decompensated cirrhosis who are already getting effective treatment (such as antiviral therapy or alcohol abstinence) * Be followed over time to check if they remain stable or have more liver problems * Have non-invasive tests done, including spleen stiffness measurement and blood tests
Researchers will track how many participants recover and stay recovered over time, and use that information to build a tool to help predict outcomes in others with cirrhosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged 18 to 75 years (inclusive)
Clinically diagnosed decompensated cirrhosis
First decompensated event occurred within 12 months of screening, or no decompensated events in the past 12 months despite a history of decompensation
For HBV: Sustained antiviral suppression
Disqualifiers
Missing data on first decompensated event
Prior orthotopic liver transplantation or TIPS
Prior splenectomy, splenic embolization, or other shunt surgery
History or current diagnosis of hepatocellular carcinoma
Trial population
Adults aged 18 to 75 years with decompensated cirrhosis who are receiving and maintaining effective treatment for the underlying cause of liver disease. The first decompensation event must be clinically significant ascites and/or variceal bleeding. Participants must have either experienced their first decompensation within the past 12 months or remained free from new decompensation events during the past 12 months.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Accuracy of non-invasive models based on spleen stiffness in predicting Recompensation
The primary outcome of this study is the accuracy of a non-invasive prediction model based on spleen stiffness and routine laboratory markers in identifying recompensation and stable recompensation in individuals with decompensated cirrhosis.
Secondary outcomes
Discrimination, calibration, and stability of the prediction model
This outcome assesses the performance of the prediction model developed to identify recompensation and stable recompensation in people with decompensated cirrhosis.
Predictive accuracy of spleen stiffness in identifying recompensation and stable recompensation
This outcome evaluates the predictive accuracy of spleen stiffness in identifying recompensation and stable recompensation among participants with decompensated cirrhosis.
Predictive accuracy of liver stiffness in identifying recompensation and stable recompensation
This outcome evaluates the predictive accuracy of liver stiffness in identifying recompensation and stable recompensation among participants with decompensated cirrhosis.
Predictive accuracy of platelets in identifying recompensation and stable recompensation
This outcome evaluates the predictive accuracy of platelet count in identifying recompensation and stable recompensation among participants with decompensated cirrhosis.
Sponsors and contacts
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