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Not yet recruitingNCT06724731Updated Dec 9, 2024

Role of Combined Ultrasound Elastography in Evaluation the Degree of Liver Fibrosis in Children with Cholesteric Liver Disease

An observational study in Liver Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
45
Ages
Up to 18 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Liver Diseases

Keywords

  • liver fibrosis
  • elastography
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In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 45 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

children patients Cholestatic Liver Disease

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
45 participants (estimated)
Patient registry
No

Groups and cohorts

  • children patients Cholestatic Liver Disease

    evaluate the diagnostic value of the Combi-Elasto technique in assessing liver fibrosis in children with cholestatic liver disease

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What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

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 34087717 ↗
  • Lendahl 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 34781099 ↗
  • Zou 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 37122598 ↗
  • Feldman 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06724731
Lead sponsor
Assiut University
Responsible party
Rehab Mohamed Abdo Hussien (resident doctor at radiology department Faculty of Medicine, Assiut University, Assiut University) — Principal investigator
First posted
Dec 9, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Dec 9, 2024

Study contacts

Rehab Mohamed Abdo Hussien, resident doctor
Contact
rhbmhmdabdo57@gmail.com
+201014258087

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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