Chronic Liver DiseaseNCT04774601
Elastography in Chronic Liver Disease in Children
An observational study of Chronic Liver Disease, run by Assiut University.
Trial summary
Chronic liver disease is a significant health issue among children and it can result in fibrosis, cirrhosis and liver failure. Since the prognosis and monitoring of these diseases are different from each other,, Conventional ultrasonography is preferred for the investigation of chronic liver diseases in children, as… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Chronic Liver Disease
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Sep 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients males and /or females from ( 0 to 18 years ) have clinical or laboratory or histopathological evidence of chronic liver disease und had undergone liver biopsy.
Who may be able to join
- 1 - all patients referred to the radiology department over the estimated period of the study. 2 - males and /or females from ( 0 to 18 years ) 3 - have clinical or laboratory or histopathological evidence of chronic liver disease 4 - had undergone liver biopsy.
Who cannot join
- - Patients males and or females older than 18 years
- - Patients who hadn't undergone liver biopsy previously
- - Patients with acute liver disease
- - Patients with human immune- deficiency virus (HIV) co infection.
- - patients with pacemaker (PM) or implantable cardioverter defibrillator (ICD) devices.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Ultrasound Elastography in the Assessment of Chronic Liver Disease in Children
Chronic liver disease is a significant health issue among children and it can result in fibrosis, cirrhosis and liver failure. Since the prognosis and monitoring of these diseases are different from each other,, Conventional ultrasonography is preferred for the investigation of chronic liver diseases in children, as it is non-invasive, cheap, feasible and available. Elastography, an ultrasonographic non-invasive procedure that measures tissue stiffness.
Read the detailed description
Chronic liver disease is a significant health issue among children and it can result in fibrosis, cirrhosis and liver failure. Since the prognosis and monitoring of these diseases are different from each other, The term chronic liver disease (CLD) implies a long standing irreversible change in the hepatic structure that may end in complications like cirrhosis leading to premature death. While liver needle biopsy is still recognised to be the gold standard for the assessment of liver fibrosis in the diagnosis and follow-up of chronic liver diseases, researchers tend to study non-invasive methods in the determination of liver fibrosis, as liver needle biopsy is an invasive, painful and expensive procedure, which can cause possible sampling errors and potential complications , Conventional ultrasonography is preferred for the investigation of chronic liver diseases in children, as it is non-invasive, cheap, feasible and available. Elastography, an ultrasonographic non-invasive procedure that measures tissue stiffness.
Liver fibrosis is a result of chronic damage, and attacks and remissions throughout the course of the disease trigger the formation of fibrosis. Apart from being a direct indicator of liver damage, fibrosis has an important role in the development of hepatocyte dysfunction and portal hypertension. In a clinical aspect, knowing the state and progress of fibrosis is important in the assessment of treatment response for the severity and the prognosis of the disease. The degree of fibrosis in the liver is important in the determination of prognosis, and management of the process in chronic liver disease. Patients with fibrosis benefit from treatment in case of early diagnosis.
Ultrasound Elastography is a non-invasive method.
- Conditions
- Chronic Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison the results of ultrasound elastography in chronic liver disease in children with histopathlogical findings .
evaluate liver stiffness as a marker of severity and duration of the underlying chronic liver disease in children to achieve early diagnosis and benefit from treatment .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study startJun 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver DiseaseStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Khalf Mohamed, Assiut University
- Investigators
- Prof.Mostafa Thabet, Professor, Study chair, Assiut UniversityProf.Mohamed koriem, Assistant professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774601
- Sponsor's protocol ID
- Elastography in liver disease
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sonmez S, Bosat M, Yurtseven N, Yurtseven E. The role of elastography in the assessment of chronic liver disease in children. Afr Health Sci. 2019 Sep;19(3):2806-2811. doi: 10.4314/ahs.v19i3.57.
PubMed 32127854
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ultrasound Elastography in the Assessment of Chronic Liver Disease in Children
- ClinicalTrials.gov ID
- NCT04774601
- Acronym / sponsor ID
- Elastography in liver disease
- Conditions
- Chronic Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 1 Mar 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.
Chronic liver disease is a significant health issue among children and it can result in fibrosis, cirrhosis and liver failure. Since the prognosis and monitoring of these diseases are different from each other,, Conventional ultrasonography is preferred for the investigation of chronic liver diseases in children, as it is non-invasive, cheap, feasible and available. Elastography, an ultrasonographic non-invasive procedure that measures tissue stiffness.
Detailed description
Chronic liver disease is a significant health issue among children and it can result in fibrosis, cirrhosis and liver failure. Since the prognosis and monitoring of these diseases are different from each other, The term chronic liver disease (CLD) implies a long standing irreversible change in the hepatic structure that may end in complications like cirrhosis leading to premature death. While liver needle biopsy is still recognised to be the gold standard for the assessment of liver fibrosis in the diagnosis and follow-up of chronic liver diseases, researchers tend to study non-invasive methods in the determination of liver fibrosis, as liver needle biopsy is an invasive, painful and expensive procedure, which can cause possible sampling errors and potential complications , Conventional ultrasonography is preferred for the investigation of chronic liver diseases in children, as it is non-invasive, cheap, feasible and available. Elastography, an ultrasonographic non-invasive procedure that measures tissue stiffness.
Liver fibrosis is a result of chronic damage, and attacks and remissions throughout the course of the disease trigger the formation of fibrosis. Apart from being a direct indicator of liver damage, fibrosis has an important role in the development of hepatocyte dysfunction and portal hypertension. In a clinical aspect, knowing the state and progress of fibrosis is important in the assessment of treatment response for the severity and the prognosis of the disease. The degree of fibrosis in the liver is important in the determination of prognosis, and management of the process in chronic liver disease. Patients with fibrosis benefit from treatment in case of early diagnosis.
Ultrasound Elastography is a non-invasive method.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients males and /or females from ( 0 to 18 years ) have clinical or laboratory or histopathological evidence of chronic liver disease und had undergone liver biopsy.
Key inclusion criteria (1 listed)
- 1 - all patients referred to the radiology department over the estimated period of the study. 2 - males and /or females from ( 0 to 18 years ) 3 - have clinical or laboratory or histopathological evidence of chronic liver disease 4 - had undergone liver biopsy.
Key exclusion criteria (5 listed)
- - Patients males and or females older than 18 years
- - Patients who hadn't undergone liver biopsy previously
- - Patients with acute liver disease
- - Patients with human immune- deficiency virus (HIV) co infection.
- - patients with pacemaker (PM) or implantable cardioverter defibrillator (ICD) devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison the results of ultrasound elastography in chronic liver disease in children with histopathlogical findings .
Time frame: Baseline
evaluate liver stiffness as a marker of severity and duration of the underlying chronic liver disease in children to achieve early diagnosis and benefit from treatment .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Background: PubMed 32127854Sonmez S, Bosat M, Yurtseven N, Yurtseven E. The role of elastography in the assessment of chronic liver disease in children. Afr Health Sci. 2019 Sep;19(3):2806-2811. doi: 10.4314/ahs.v19i3.57.
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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.
Prof.Mostafa Thabet, Professor study chair
Assiut University
Prof.Mohamed koriem, Assistant professor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease, 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 5 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 29 Mar 2021. 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 Mostafa Khalf, Resident (01550789590, mostafakhalf@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison the results of ultrasound elastography in chronic liver disease in children with histopathlogical findings . (time frame: Baseline). 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 NCT04774601, which also lists 1 linked publication.
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 29 Mar 2021.