A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorBeijing Friendship Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

735 Participants
are grouped into 2 trial groups
Group A: Recompensation group
Group B: Non-recompensation group

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

1

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.

Time frame
2 years
2

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.

Time frame
2 years
3

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.

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: