HEPATITIS B CHRONIC, Liver Cirrhosis, Liver Fibrosis, NAFLD (Nonalcoholic Fatty Liver Disease)
Conditions
Brief summary
Liver stiffness measurement is a key non-invasive tool for assessing liver fibrosis and cirrhosis in patients with chronic liver disease. Transient elastography (FibroScan) is currently the most widely used non-invasive reference standard, but it requires a dedicated device and trained operator, which may limit its accessibility in some clinical settings. This study aims to evaluate the diagnostic accuracy of a novel wearable patch-type ultrasound probe for detecting significant liver fibrosis and cirrhosis, using FibroScan as the reference standard. Patients with chronic liver disease will undergo simultaneous liver stiffness measurement using both the wearable patch ultrasound probe and FibroScan. The diagnostic performance of the patch probe, including sensitivity, specificity, and area under the receiver operating characteristic curve (AUC), will be evaluated against fibrosis staging determined by FibroScan, along with the correlation and agreement between the two measurement methods.
Detailed description
Chronic liver disease, including chronic viral hepatitis, non-alcoholic fatty liver disease (NAFLD), and alcohol-related liver disease, can progress to liver fibrosis and, ultimately, cirrhosis if left undetected and untreated. Accurate and timely assessment of liver fibrosis stage is essential for guiding clinical management, including treatment initiation, monitoring of disease progression, and screening for cirrhosis-related complications such as esophageal varices and hepatocellular carcinoma. Liver biopsy has traditionally been considered the gold standard for assessing liver fibrosis; however, it is invasive, carries risk of complications, and is subject to sampling variability. Transient elastography (FibroScan) has emerged as a widely validated non-invasive alternative, providing a reliable estimate of liver stiffness that correlates with fibrosis stage. However, FibroScan requires a dedicated, non-portable device and a trained operator, and access may be limited in certain clinical settings, particularly outside of specialized hepatology centers. Wearable ultrasound technology has advanced substantially in recent years, offering the potential for a simplified, patch-type probe that can be applied directly to the skin over the liver to estimate tissue stiffness. Such a device could potentially lower the technical barrier for liver stiffness assessment and expand access to non-invasive fibrosis screening. However, the diagnostic accuracy of this wearable patch-type ultrasound probe for detecting clinically significant fibrosis and cirrhosis has not yet been established in a clinical population. This study is a prospective cross-sectional diagnostic accuracy study. Patients with chronic liver disease will be enrolled and will undergo liver stiffness measurement using both the investigational wearable patch-type ultrasound probe and FibroScan (transient elastography) at the same clinical visit. FibroScan results will be used as the reference standard to classify patients according to fibrosis stage, including significant fibrosis (≥F2) and cirrhosis (F4). The diagnostic performance of the wearable patch ultrasound probe will be evaluated by calculating sensitivity, specificity, positive predictive value, negative predictive value, and the area under the receiver operating characteristic curve (AUC) for each clinically relevant fibrosis threshold, along with the corresponding optimal cut-off values. In addition, the correlation and agreement between liver stiffness values obtained from the wearable patch probe and FibroScan will be assessed using Pearson correlation coefficient and Bland-Altman analysis. The results of this study are expected to provide preliminary evidence on whether the wearable patch-type ultrasound probe can serve as a reliable, accessible, non-invasive tool for the diagnosis of liver fibrosis and cirrhosis in patients with chronic liver disease.
Interventions
DEVICEWearable Patch-Type Ultrasound Probe
An investigational patch-type ultrasound probe applied to the skin over the liver to non-invasively estimate liver tissue stiffness. Measurement results will be compared against the reference standard to evaluate diagnostic accuracy for detecting significant fibrosis and cirrhosis.
A validated, widely used non-invasive reference standard device for measuring liver stiffness, used to classify patients according to fibrosis stage (e.g., significant fibrosis ≥F2, cirrhosis F4).
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Confirmed or suspected chronic liver disease (including but not limited to chronic viral hepatitis, non-alcoholic fatty liver disease, and alcohol-related liver disease) * Scheduled to undergo, or have recently undergone, transient elastography (FibroScan) as part of routine clinical care * Age ≥ 18 years * Willing and able to provide signed informed consent
Exclusion criteria
* Ascites (may interfere with liver stiffness measurement by either device) Body mass index (BMI) ≥ 35 kg/m² (may reduce measurement reliability of transient elastography) * Acute hepatitis or acute-on-chronic liver failure at the time of enrollment * History of liver transplantation * Hepatocellular carcinoma or other space-occupying liver lesions * Pregnant women * Skin lesions, infection, or scarring at the intended probe application site (right lobe of the liver, intercostal space) * Unable to cooperate with the measurement procedure (e.g., severe cognitive impairment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Receiver Operating Characteristic Curve (AUC) for Detecting Significant Liver Fibrosis (≥F2) | Baseline (Day 1) | The AUC of the wearable patch ultrasound probe for distinguishing patients with significant fibrosis (≥F2) from those with no/mild fibrosis (F0-F1), using FibroScan-determined fibrosis stage as the reference standard. |
| Area Under the Receiver Operating Characteristic Curve (AUC) for Detecting Cirrhosis (F4) | Baseline (Day 1) | The AUC of the wearable patch ultrasound probe for distinguishing patients with cirrhosis (F4) from those without cirrhosis (F0-F3), using FibroScan-determined fibrosis stage as the reference standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation and Agreement Between Wearable Patch Ultrasound Probe and Reference Standard Liver Stiffness Measurements | At the time of enrollment (single time-point assessment) | Agreement between liver stiffness values obtained from the wearable patch ultrasound probe and the reference standard (FibroScan) will be assessed using Pearson correlation coefficient and Bland-Altman analysis to evaluate systematic bias and limits of agreement across the full range of measured values. |
| Correlation Coefficient Between Wearable Patch Ultrasound Probe and FibroScan Liver Stiffness Measurements, Stratified by Fibrosis Severity Subgroup | Baseline (Day 1) | Patients will be stratified into subgroups based on FibroScan-determined fibrosis stage (no/mild fibrosis \[F0-F1\], significant fibrosis \[F2-F3\], and cirrhosis \[F4\]). Within each subgroup, the Pearson correlation coefficient between liver stiffness values (measured in kPa) obtained from the wearable patch ultrasound probe and FibroScan will be calculated to assess whether measurement agreement varies with disease severity. |
| Sensitivity of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2) | Baseline (Day 1) | Sensitivity of the wearable patch ultrasound probe, at the optimal cut-off value, for detecting significant fibrosis (≥F2), using FibroScan-determined fibrosis stage as the reference standard. |
| Specificity of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2) | Baseline (Day 1) | Specificity of the wearable patch ultrasound probe, at the optimal cut-off value, for detecting significant fibrosis (≥F2), using FibroScan-determined fibrosis stage as the reference standard. |
| Sensitivity of the Wearable Patch Ultrasound Probe for Detecting Cirrhosis (F4) | Baseline (Day 1) | Sensitivity of the wearable patch ultrasound probe, at the optimal cut-off value, for detecting cirrhosis (F4), using FibroScan-determined fibrosis stage as the reference standard. |
| Specificity of the Wearable Patch Ultrasound Probe for Detecting Cirrhosis (F4) | Baseline (Day 1) | Specificity of the wearable patch ultrasound probe, at the optimal cut-off value, for detecting cirrhosis (F4), using FibroScan-determined fibrosis stage as the reference standard. |
| Positive Predictive Value (PPV) of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2) | Baseline (Day 1) | PPV of the wearable patch ultrasound probe, at the optimal cut-off value, for detecting significant fibrosis (≥F2), using FibroScan-determined fibrosis stage as the reference standard. |
| Negative Predictive Value (NPV) of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2) | Baseline (Day 1) | NPV of the wearable patch ultrasound probe, at the optimal cut-off value, for detecting significant fibrosis (≥F2), using FibroScan-determined fibrosis stage as the reference standard. |
| Correlation and Agreement Between Wearable Patch Ultrasound Probe and FibroScan Liver Stiffness Measurements | Baseline (Day 1) | Agreement between liver stiffness values obtained from the wearable patch ultrasound probe and FibroScan will be assessed using Pearson correlation coefficient and Bland-Altman analysis to evaluate systematic bias and limits of agreement. |
Contacts
CONTACTKai Qu
Outcome results
None listed