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Predictive Power of Share Wave Fibro Scan in HCC After HCV Infection

Predictive Power of Share Wave Fibro Scan in HCC After HCV Infection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05105828
Enrollment
110
Registered
2021-11-03
Start date
2020-07-01
Completion date
2021-04-30
Last updated
2021-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief summary

Shear wave electrography score allows stratification of HCC risk in a noninvasive and reliable way and can guide the surveillance strategy for HCC in patients with CLD

Detailed description

Liver fibrosis is common to all chronic liver disease (CLD) , With time, this progressive disruption of hepatic architecture can develop into cirrhosis, characterized by diffuse conversion of normal liver architecture into structurally abnormal nodules, About1% to 4% of patients with HCV-induced liver cirrhosis are diagnosed with HCC each year . The historical gold standard for quantifying fibrosis is liver biopsy, but its invasive nature and potential for complications make it unpopular among patients and impractical for serial assessments of CLD. Furthermore, since histological lesions are not uniformly distributed across the liver parenchyma, this allows for large sampling error. The need for credible alternatives to biopsy has stimulated research into non-invasive methods of fibrosis assessment, including serum biomarkers , axial imaging and transient elastography. FibroScan™ (Echosens, Paris, France) allows a non-invasive liver stiffness measurement (LSM), it is a relatively simple, highly reproducible and operator independent technique which examines an area 100 times that of a biopsy, reducing sampling bias , Shear wave elastography (SWE) measures LS by quantifying the velocity of shear waves produced in the liver tissue and uses a normal B-mode ultrasound probe for measuring LS in real time. In addition, SWE imaging using the Aixplorer system provides a high frame-rate and may be able to provide more accurate scoring of fibrosis .

Interventions

DIAGNOSTIC_TESTShare wave fibro scan

Shear wave elastography (SWE) measures LS by quantifying the velocity of shear waves produced in the liver tissue and uses a normal B-mode ultrasound probe for measuring LS in real time. In addition, SWE imaging using the Aixplorer system provides a high frame-rate and may be able to provide more accurate scoring of fibrosis

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Post hepatitis C with HCC

Exclusion criteria

* hepatic encephalopathy, ascites or pregnancy, hepatorenal syndrome or hepato-pulmonary syndrome, right side heart failure (liver congestion), extra hepatic tumors, history of liver transplantation, cholestasis, and hepatitis B patient

Design outcomes

Primary

MeasureTime frameDescription
Shear wave elastography scorethrough study completion, an average of 1 yearit measures liver stiffness as it is a rapid technique taking less than 5 min that can be easily performed at bedside or in outpatient clinic,according to the manufacturer's recommendations and the machine scale result ranges from 2.5 to 75 kPa with normal value around 5.5 kPa

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026