Liver and Spleen Stiffness Measured by 2D-SWE for Diagnosis of Liver Fibrosis in Patients With cACLD (NCT06147934) | Clinical Trial Compass
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Liver and Spleen Stiffness Measured by 2D-SWE for Diagnosis of Liver Fibrosis in Patients With cACLD
China150 participantsStarted 2023-11-01
Plain-language summary
A observational diagnostic study will be conducted to evaluate the performance of liver stiffness and spleen stiffness measured by 2D-shear wave elastography (2D-SWE) for diagnosing liver fibrosis in people with compensated Advanced Chronic Liver Disease (cACLD), and explore the cut-off value of 2D-SWE for diagnosing liver fibrosis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age≥18 years old;
* Chronic liver disease (alcoholic liver disease, chronic hepatitis B, chronic hepatitis C or non-alcoholic fatty liver disease);
* No previous decompensation-related manifestations (such as ascites, gastrointestinal varicose bleeding, hepatic encephalopathy, etc.);
* Informed consent has been signed.
Exclusion Criteria:
* Hepatocellular carcinoma or other advanced malignant tumor;
* Acute liver disease or ALT≥5×ULN;
* Persistent substance abuse other than alcohol;
* Pregnancy or HIV infection;
* There are contraindications of percutaneous liver biopsy (such as serious abnormality of coagulation function, etc.);
* There are conditions that seriously affect TE and 2D-SWE measurements (such as the intercostal space is too narrow, BMI≥30, etc.);
* Subjects considered unsuitable for including in this study but not included by the above exclusion criteria.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of 2D-SWE
Timeframe: Through study completion, an average of 2 year
2
Specificity of 2D-SWE
Timeframe: Through study completion, an average of 2 year
3
Positive Predictive Value of 2D-SWE
Timeframe: Through study completion, an average of 2 year
4
Negative Predictive Value of TE and 2D-SWE
Timeframe: Through study completion, an average of 2 year
5
Overall diagnostic performance of TE and 2D-SWE
Timeframe: Through study completion, an average of 2 year
Trial details
NCT IDNCT06147934
SponsorFifth Affiliated Hospital, Sun Yat-Sen University