Liver DiseasesNCT06724731
Role of Combined Ultrasound Elastography in Evaluation the Degree of Liver Fibrosis in Children With Cholesteric Liver Disease
An observational study of Liver Diseases, run by Assiut University.
Trial summary
Pediatric CLDs are diverse, encompassing a broad spectrum of conditions, from congenital and metabolic disorders to autoimmune and viral diseases. These chronic liver conditions in children often carry the risk of progressing to fibrosis and cirrhosis. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Liver Diseases
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children patients Cholestatic Liver Disease
Who may be able to join
- Participants must be aged between 0 and 18 years at the time of enrollment.
- Children must have a confirmed diagnosis of cholestatic liver disease, supported by:
- Histological confirmation via liver biopsy showing cholestasis.
- Clinical evidence of cholestasis, such as elevated alkaline phosphatase levels or conjugated hyperbilirubinemia.
- Participants should have a documented history of cholestatic liver disease for at least three months prior to enrollment to ensure that the condition is chronic and allows for adequate assessment of fibrosis progression.
Who cannot join
- patients without prehepatic ascites
- patients with hepatic space-occupying lesions.
- patients with other serious systemic diseases, such as heart failure, renal failure and mental illness
- patients after liver transplantation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Pediatric CLDs are diverse, encompassing a broad spectrum of conditions, from congenital and metabolic disorders to autoimmune and viral diseases. These chronic liver conditions in children often carry the risk of progressing to fibrosis and cirrhosis. Additionally, certain liver diseases in children exhibit unique characteristics, including varying rates of fibrosis progression. For example, while fibrosis typically takes months to develop in most patients, it progresses much faster in neonates . Approximately 1%-2% of adults, but a significantly higher 17%-30% of children, progress to advanced liver disease and require liver transplantation annually.
the aim of the study to evaluate the diagnostic value of Combi-Elasto technique in detecting degree of liver fibrosis in children with Cholestatic Liver Disease
Read the detailed description
The prevalence of chronic liver disease (CLD) among children is on the rise globally, driven by various epidemiological shifts, such as the opioid crisis contributing to hepatitis C infections and the obesity epidemic leading to nonalcoholic fatty liver disease (NAFLD) . liver disease affects 1 in every 2,500 infants, and in 2021, children accounted for 13% of all liver transplants in the United States .
Currently, there are no effective pharmacological treatments to prevent or slow the progression of Cholestatic Liver Disease in children. As a result, it is crucial to evaluate the extent of liver fibrosis in children with cholestatic liver disease as early as possible. Early assessment is vital for delaying disease progression, decreasing the need for liver transplantation, and providing essential information for clinical decision-making when transplantation becomes necessary.
Combi-Elasto technique, which integrates elastography with other non-invasive imaging modalities, has emerged as a promising tool for evaluating liver fibrosis. This approach offers several potential benefits, including enhanced diagnostic accuracy, safety, and the ability to assess fibrosis without the need for invasive procedures. Combi-elasto (CE) integrates the benefits of both strain elastography and shear wave elastography. It uses the fibrosis index (FI), activity index (AI), and attenuation coefficient (ATT) to provide precise evaluations of fibrosis levels, inflammation activity, and fatty degeneration.
- Conditions
- Liver Diseases
- Keywords
- liver fibrosis, elastography
- Medical subject headings
- Liver Diseases, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children patients Cholestatic Liver Disease | evaluate the diagnostic value of the Combi-Elasto technique in assessing liver fibrosis in children with cholestatic liver disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
the accuracy of the Combi-Elasto technique in determining the degree of liver fibrosis in children
sensitivity, and specificity of the Combi-Elasto technique in determining the degree of liver fibrosis in children
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (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 Liver DiseasesStudies 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
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Mohamed Abdo Hussien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724731
- Sponsor's protocol ID
- elastography cholesteric liver
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhao Y, Wu L, Qin H, Li Q, Shen C, He Y, Yang H. Preoperative combi-elastography for the prediction of early recurrence after curative resection of hepatocellular carcinoma. Clin Imaging. 2021 Nov;79:173-178. doi: 10.1016/j.clinimag.2021.05.020. Epub 2021 May 31.
PubMed 34087717Lendahl U, Lui VCH, Chung PHY, Tam PKH. Biliary Atresia - emerging diagnostic and therapy opportunities. EBioMedicine. 2021 Dec;74:103689. doi: 10.1016/j.ebiom.2021.103689. Epub 2021 Nov 12.
PubMed 34781099Zou YG, Wang H, Li WW, Dai DL. Challenges in pediatric inherited/metabolic liver disease: Focus on the disease spectrum, diagnosis and management of relatively common disorders. World J Gastroenterol. 2023 Apr 14;29(14):2114-2126. doi: 10.3748/wjg.v29.i14.2114.
PubMed 37122598Feldman AG, Sokol RJ. Neonatal cholestasis: emerging molecular diagnostics and potential novel therapeutics. Nat Rev Gastroenterol Hepatol. 2019 Jun;16(6):346-360. doi: 10.1038/s41575-019-0132-z.
PubMed 30903105
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Combined Ultrasound Elastography in Evaluation the Degree of Liver Fibrosis in Children With Cholesteric Liver Disease
- ClinicalTrials.gov ID
- NCT06724731
- Acronym / sponsor ID
- elastography cholesteric liver
- Conditions
- Liver Diseases
- Keywords
- liver fibrosis, elastography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 Dec 2024 (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.
Pediatric CLDs are diverse, encompassing a broad spectrum of conditions, from congenital and metabolic disorders to autoimmune and viral diseases. These chronic liver conditions in children often carry the risk of progressing to fibrosis and cirrhosis. Additionally, certain liver diseases in children exhibit unique characteristics, including varying rates of fibrosis progression. For example, while fibrosis typically takes months to develop in most patients, it progresses much faster in neonates . Approximately 1%-2% of adults, but a significantly higher 17%-30% of children, progress to advanced liver disease and require liver transplantation annually.
the aim of the study to evaluate the diagnostic value of Combi-Elasto technique in detecting degree of liver fibrosis in children with Cholestatic Liver Disease
Detailed description
The prevalence of chronic liver disease (CLD) among children is on the rise globally, driven by various epidemiological shifts, such as the opioid crisis contributing to hepatitis C infections and the obesity epidemic leading to nonalcoholic fatty liver disease (NAFLD) . liver disease affects 1 in every 2,500 infants, and in 2021, children accounted for 13% of all liver transplants in the United States .
Currently, there are no effective pharmacological treatments to prevent or slow the progression of Cholestatic Liver Disease in children. As a result, it is crucial to evaluate the extent of liver fibrosis in children with cholestatic liver disease as early as possible. Early assessment is vital for delaying disease progression, decreasing the need for liver transplantation, and providing essential information for clinical decision-making when transplantation becomes necessary.
Combi-Elasto technique, which integrates elastography with other non-invasive imaging modalities, has emerged as a promising tool for evaluating liver fibrosis. This approach offers several potential benefits, including enhanced diagnostic accuracy, safety, and the ability to assess fibrosis without the need for invasive procedures. Combi-elasto (CE) integrates the benefits of both strain elastography and shear wave elastography. It uses the fibrosis index (FI), activity index (AI), and attenuation coefficient (ATT) to provide precise evaluations of fibrosis levels, inflammation activity, and fatty degeneration.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children patients Cholestatic Liver Disease | – | –evaluate the diagnostic value of the Combi-Elasto technique in assessing liver fibrosis in children with cholestatic liver disease |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children patients Cholestatic Liver Disease
Key inclusion criteria (5 listed)
- Participants must be aged between 0 and 18 years at the time of enrollment.
- Children must have a confirmed diagnosis of cholestatic liver disease, supported by:
- Participants should have a documented history of cholestatic liver disease for at least three months prior to enrollment to ensure that the condition is chronic and allows for adequate assessment of fibrosis progression.
Key exclusion criteria (4 listed)
- patients without prehepatic ascites
- patients with hepatic space-occupying lesions.
- patients with other serious systemic diseases, such as heart failure, renal failure and mental illness
- patients after liver transplantation.
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
the accuracy of the Combi-Elasto technique in determining the degree of liver fibrosis in children
Time frame: baseline
sensitivity, and specificity of the Combi-Elasto technique in determining the degree of liver fibrosis in children
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Results publication: PubMed 34087717Zhao Y, Wu L, Qin H, Li Q, Shen C, He Y, Yang H. Preoperative combi-elastography for the prediction of early recurrence after curative resection of hepatocellular carcinoma. Clin Imaging. 2021 Nov;79:173-178. doi: 10.1016/j.clinimag.2021.05.020. Epub 2021 May 31.
- Results publication: PubMed 34781099Lendahl U, Lui VCH, Chung PHY, Tam PKH. Biliary Atresia - emerging diagnostic and therapy opportunities. EBioMedicine. 2021 Dec;74:103689. doi: 10.1016/j.ebiom.2021.103689. Epub 2021 Nov 12.
- Results publication: PubMed 37122598Zou YG, Wang H, Li WW, Dai DL. Challenges in pediatric inherited/metabolic liver disease: Focus on the disease spectrum, diagnosis and management of relatively common disorders. World J Gastroenterol. 2023 Apr 14;29(14):2114-2126. doi: 10.3748/wjg.v29.i14.2114.
- Results publication: PubMed 30903105Feldman AG, Sokol RJ. Neonatal cholestasis: emerging molecular diagnostics and potential novel therapeutics. Nat Rev Gastroenterol Hepatol. 2019 Jun;16(6):346-360. doi: 10.1038/s41575-019-0132-z.
- Individual participant dataSharing planned: Undecided
Related trials for Liver Diseases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rehab Mohamed Abdo Hussien, resident doctor (+201014258087, rhbmhmdabdo57@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the accuracy of the Combi-Elasto technique in determining the degree of liver fibrosis in children (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 NCT06724731, 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 9 Dec 2024.