Chronic HepaticNCT05163132
Shear-wave Elastography Diffuse Liver Disease
An observational study of Chronic Hepatic and Chronic Liver Disease and Cirrhosis, run by Assiut University.
Trial summary
The aim of this study is to correlate between quantitative results of shear wave elastography and CT picture in diffuse liver disease, including liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatic, Chronic Liver Disease and Cirrhosis
- What is being tested?
- Shearwave elastography
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: Patients who diagnosed to had chronic liver diseases with or without present hepatic focal lesions.
Who may be able to join
- Both sexes are included: patients who diagnosed to had chronic liver diseases with or without present hepatic focal lesions.
Who cannot join
- Lactating and pregnant women
- Patients known to had high serum creatinine
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Correlation Between Shear-wave Elastography and CT in Diffuse Liver Disease
The aim of this study is to correlate between quantitative results of shear wave elastography and CT picture in diffuse liver disease, including liver cirrhosis.
Read the detailed description
Many pathophysiological processes can lead to diffuse parenchymal liver diseases and the end-result of all chronic liver diseases is healing by fibrosis and regeneration. Liver fibrosis is a slowly progressing disease in which healthy liver tissue is replaced with scar tissue ended with liver cirrhosis, with a variety of causes, including viral, drug induced, autoimmune, cholestatic, and metabolic diseases.
Liver biopsy is the gold standard but limited due to its invasiveness, sampling error, and intra- and interobserver variability. Non-invasive tests are preferred in the management of chronic liver diseases. Several serum tests for liver function and markers of liver fibrosis are available and have moderate sensitivity and specificity; however, they are confounded by a wide range of extra-hepatic diseases.
Currently, several methods are available for assessing hepatic fibrosis and progression of fibrogenesis including scintigraphy, magnetic resonance diffusion weighted imaging, and magnetic resonance spectroscopy could differentiate between cirrhosis or severe fibrosis and normal liver. However, an accurate staging of fibrosis or diagnosis of mild fibrosis was often not achievable. Shear-wave elastography (SWE) is a real-time freehand ultrasonography-based elastography method for liver stiffness measurement.
- Being tested
- Shearwave elastography
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shearwave elastographyDevice
Shear wave elastography is an ultrasound applied technique used to measure tissue stiffness as a result of a disease. So, it can be used to evaluate liver stiffness as a result of liver cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Shearwave elastography (SWE) of the liver
Analyze the correlation between SWE of liver and with computed tomography findings.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic HepaticStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel-Tawab Mohamed, Assiut University
- Investigators
- Mohamed Abdeltawab, MD, Study director, AssiutHayam M Abd El-hakeem, Principal investigator, Assiut UniversityEman Abo El-hamd, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163132
- Sponsor's protocol ID
- Fibroscan
- Status last verified
- Dec 2021
- First submitted
- 6 Dec 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boll DT, Merkle EM. Diffuse liver disease: strategies for hepatic CT and MR imaging. Radiographics. 2009 Oct;29(6):1591-614. doi: 10.1148/rg.296095513.
PubMed 19959510Lingala S, Ghany MG. Natural History of Hepatitis C. Gastroenterol Clin North Am. 2015 Dec;44(4):717-34. doi: 10.1016/j.gtc.2015.07.003. Epub 2015 Aug 25.
PubMed 26600216Wilkins T, Akhtar M, Gititu E, Jalluri C, Ramirez J. Diagnosis and Management of Hepatitis C. Am Fam Physician. 2015 Jun 15;91(12):835-42.
PubMed 26131943Ferraioli 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.
PubMed 22767302
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Shear-wave Elastography and CT in Diffuse Liver Disease
- ClinicalTrials.gov ID
- NCT05163132
- Acronym / sponsor ID
- Fibroscan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to correlate between quantitative results of shear wave elastography and CT picture in diffuse liver disease, including liver cirrhosis.
Detailed description
Many pathophysiological processes can lead to diffuse parenchymal liver diseases and the end-result of all chronic liver diseases is healing by fibrosis and regeneration. Liver fibrosis is a slowly progressing disease in which healthy liver tissue is replaced with scar tissue ended with liver cirrhosis, with a variety of causes, including viral, drug induced, autoimmune, cholestatic, and metabolic diseases.
Liver biopsy is the gold standard but limited due to its invasiveness, sampling error, and intra- and interobserver variability. Non-invasive tests are preferred in the management of chronic liver diseases. Several serum tests for liver function and markers of liver fibrosis are available and have moderate sensitivity and specificity; however, they are confounded by a wide range of extra-hepatic diseases.
Currently, several methods are available for assessing hepatic fibrosis and progression of fibrogenesis including scintigraphy, magnetic resonance diffusion weighted imaging, and magnetic resonance spectroscopy could differentiate between cirrhosis or severe fibrosis and normal liver. However, an accurate staging of fibrosis or diagnosis of mild fibrosis was often not achievable. Shear-wave elastography (SWE) is a real-time freehand ultrasonography-based elastography method for liver stiffness measurement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients who diagnosed to had chronic liver diseases with or without present hepatic focal lesions.
Key inclusion criteria (1 listed)
- Both sexes are included: patients who diagnosed to had chronic liver diseases with or without present hepatic focal lesions.
Key exclusion criteria (2 listed)
- Lactating and pregnant women
- Patients known to had high serum creatinine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shearwave elastographyShear wave elastography is an ultrasound applied technique used to measure tissue stiffness as a result of a disease. So, it can be used to evaluate liver stiffness as a result of liver cirrhosis | Device | – |
Primary outcome
Shearwave elastography (SWE) of the liver
Time frame: 1 week
Analyze the correlation between SWE of liver and with computed tomography findings.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Results publication: PubMed 19959510Boll DT, Merkle EM. Diffuse liver disease: strategies for hepatic CT and MR imaging. Radiographics. 2009 Oct;29(6):1591-614. doi: 10.1148/rg.296095513.
- Results publication: PubMed 26600216Lingala S, Ghany MG. Natural History of Hepatitis C. Gastroenterol Clin North Am. 2015 Dec;44(4):717-34. doi: 10.1016/j.gtc.2015.07.003. Epub 2015 Aug 25.
- Results publication: PubMed 26131943Wilkins T, Akhtar M, Gititu E, Jalluri C, Ramirez J. Diagnosis and Management of Hepatitis C. Am Fam Physician. 2015 Jun 15;91(12):835-42.
- Results publication: PubMed 22767302Ferraioli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Abdeltawab, MD study director
Assiut
Hayam M Abd El-hakeem principal investigator
Assiut University
Eman Abo El-hamd study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatic and Chronic Liver Disease and Cirrhosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdeltawab, MD (+201009319309 ext. +20, dr.m.tawab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shearwave elastography (SWE) of the liver (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05163132, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.