Evaluating liver and spleen stiffness for diagnosing liver fibrosis in patients with chronic liver disease
Liver and Spleen Stiffness Measured by 2D-shear Wave Elastography for Diagnosis of Liver Fibrosis in Patients With Compensated Advanced Chronic Liver Disease: a Diagnostic Accuracy Study
This study is testing if measuring the stiffness of the liver and spleen can help diagnose liver fibrosis in people with chronic liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fifth Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Zhuhai, Guangdong) |
| Trial ID | NCT06147934 on ClinicalTrials.gov |
What this trial studies
This observational diagnostic study aims to assess the effectiveness of liver and spleen stiffness measurements using 2D-shear wave elastography (2D-SWE) in diagnosing liver fibrosis in individuals with compensated Advanced Chronic Liver Disease (cACLD). Patients will undergo a series of tests, including abdominal ultrasound and transient elastography, to gather data on liver and spleen stiffness. The study will enroll participants from the Fifth Affiliated Hospital, Sun Yat-Sen University, from October 2023 to January 2025, focusing on those with specific eligibility criteria. The goal is to establish a cut-off value for 2D-SWE that can aid in the diagnosis of liver fibrosis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic liver disease who have not experienced any decompensation symptoms.
Not a fit: Patients with hepatocellular carcinoma, acute liver disease, or other serious conditions affecting the study's measurements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for accurately diagnosing liver fibrosis, improving patient management and outcomes.
How similar studies have performed: Other studies have shown promise in using elastography techniques for liver fibrosis diagnosis, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Zhuhai, Guangdong
- The Fifth Affiliated Hospital, Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Xi Liu, PhD — The Fifth Affiliated Hospital, Sun Yat-sen University
- Study coordinator: Xi Liu, PhD
- Email: liuxi26@mail.sysu.edu.cn
- Phone: +86 15992670630
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.