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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05105828
• Other study ID #: Share wave fibro scan in HCC
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 30, 2021
• Est. primary completion date: October 30, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatitis C
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• Share 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

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

Taylor-Robinson SD. Applications of magnetic resonance spectroscopy to chronic liver disease. Clin Med (Lond). 2001 Jan-Feb;1(1):54-60. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shear wave elastography score	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