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

NCT06724731 | Not Yet Recruiting DMC

• 1 other identifier: elastography cholesteric liver
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Liver Diseases

Keywords

liver fibrosis; elastography

Outcome Measures

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

  baseline

Study Arms (1)

children patients Cholestatic Liver Disease

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

children patients Cholestatic Liver Disease

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 34087717 BACKGROUND

• 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.

  PMID: 34781099 BACKGROUND

• 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.

  PMID: 37122598 BACKGROUND

• 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.

  PMID: 30903105 BACKGROUND

MeSH Terms

Conditions

Liver Diseases; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rehab Mohamed Abdo Hussien, resident doctor

CONTACT

+201014258087; rhbmhmdabdo57@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at radiology department Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 9, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 9, 2024

Record last verified: 2024-11