- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05105828
Predictive Power of Share Wave Fibro Scan in HCC After HCV Infection
Study Overview
Status
Conditions
Intervention / Treatment
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 .
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Assiut, Egypt, 71515
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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post Hepatitis C patients with hepatocellular carcinoma
post Hepatitis C patients with hepatocellular carcinoma above 18 years
|
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
|
control group
post Hepatitis C patients without hepatocellular carcinoma above 18 years
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shear wave elastography score
Time Frame: through study completion, an average of 1 year
|
it 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
|
through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Tsochatzis EA, Bosch J, Burroughs AK. Liver cirrhosis. Lancet. 2014 May 17;383(9930):1749-61. doi: 10.1016/S0140-6736(14)60121-5. Epub 2014 Jan 28.
- Sumida Y, Nakajima A, Itoh Y. Limitations of liver biopsy and non-invasive diagnostic tests for the diagnosis of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. World J Gastroenterol. 2014 Jan 14;20(2):475-85. doi: 10.3748/wjg.v20.i2.475.
- Taylor-Robinson SD. Applications of magnetic resonance spectroscopy to chronic liver disease. Clin Med (Lond). 2001 Jan-Feb;1(1):54-60. doi: 10.7861/clinmedicine.1-1-54.
- Ferraioli G, Tinelli C, Dal Bello B, Zicchetti M, Filice G, Filice C; Liver Fibrosis Study Group. Accuracy of real-time shear wave elastography for assessing liver fibrosis in chronic hepatitis C: a pilot study. Hepatology. 2012 Dec;56(6):2125-33. doi: 10.1002/hep.25936. Epub 2012 Aug 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Liver Neoplasms
- Hepatitis
- Carcinoma, Hepatocellular
- Hepatitis C
Other Study ID Numbers
- Share wave fibro scan in HCC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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