Predictive Power of Share Wave Fibro Scan in HCC After HCV Infection
1 other identifier
observational
110
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedFirst Submitted
Initial submission to the registry
October 23, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedNovember 3, 2021
April 1, 2020
4 months
October 23, 2021
October 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
post Hepatitis C patients with hepatocellular carcinoma
post Hepatitis C patients with hepatocellular carcinoma above 18 years
control group
post Hepatitis C patients without hepatocellular carcinoma above 18 years
Interventions
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
Eligibility Criteria
Post hepatitis C with HCC above 18 years
You may qualify if:
- Post hepatitis C with HCC
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, 71515, Egypt
Related Publications (4)
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.
PMID: 24480518BACKGROUNDSumida 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.
PMID: 24574716BACKGROUNDTaylor-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.
PMID: 11358078BACKGROUNDFerraioli 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.
PMID: 22767302BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
October 23, 2021
First Posted
November 3, 2021
Study Start
July 1, 2020
Primary Completion
October 30, 2020
Study Completion
April 30, 2021
Last Updated
November 3, 2021
Record last verified: 2020-04