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Not yet recruitingNCT06773390Updated Jan 14, 2025

Percutaneos Liver Biopsy in Pediatric Patient : Diagnostic Significance and Pattern of Liver Diseases

An observational study in Percutaneous Liver Biopsy, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
40
Ages
1 Year to 18 Years
Sex
All
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Study summary

In this study, we aim to evaluate the spectrum and pattern of liver diseases diagnosed by percutaneous tru-cut needle liver biopsy.

Read the detailed description

Liver disease has a wide varied range of diseases that affect liver. In pediatrics, liver diseases can be categorized according to the underlying cause into: Acquired liver disease (as viral hepatitis, non-viral hepatitis, fatty liver, etc.), Autoimmune liver disease (Type1 autoimmune hepatitis, type 2 autoimmune hepatitis; thats more common in pediatrics), Congenital anomalies (biliary atresia, biliary (choledochal) cyst, Alagille syndrome), Metabolic liver disorder, a group of diseases occur when there is an abnormal gene in the metabolic pathway resulting in affection of the enzyme function, structure or amount, and Genetic diseases of liver (as Alpha 1 Antitrypsin Deficiency thats the most common genetic cause of liver disease in children) (1). However, liver disease may be part of a syndrome. In general, liver diseases are often asymptomatic in children; however commonest presenting signs and symptoms include jaundice, vomiting, coagulopathy or hepatomegaly (2,3).

In neonates, the first week of life is the mean age of onset of biliary atresia and galactosemia; however, symptoms may present in infancy. Also, viral hepatitis is commonly asymptomatic in neonates. In case of infants and children below 5 years, they may experience more presentation in liver disease. For example; glycogen storage diseases, alpha-1 antitrypsin deficiency, autoimmune hepatitis and others are more presented in the first five years of life. In neonates, infants and children; liver diseases are more common in males rather than females, except in autoimmune liver diseases; females are more common (2).

Diagnosis of liver disease in pediatrics represents a challenge because the majority of pediatrics has no symptoms especially in the early stages. Diagnostic tools of liver disease vary between laboratory investigation as Complete blood count (CBC), Liver function test (LFT), Viral markers, etc., imaging as abdominal ultrasonography (US), abdominal Computed tomography (CT),magnetic resonance imaging (MRI) and / or liver biopsy (4).

Liver biopsy is considered the best diagnostic tool in multiple diseases of liver and help clinicians in decision making. There are several types of liver biopsy: Percutaneous Liver Biopsy (PLB): it is the less invasive and the frequent used modality that can be conducted through physical examination (percussion over the upper right quadrant of the abdomen) or by sonar guidance. Trans-jugular Liver Biopsy; this technique is performed when patient has severe liver disease and coagulopathies or haematological condition and PLB is contraindicated. Surgical or Laparoscopic Liver biopsy; although it provides a large specimen size, it is done when there is increased risk of bleeding or in ascites of unknown cause and according to European Society for Pediatric Gastroenterology Hepatology and Nutrition

(ESPGHAN) laparoscopic liver biopsy used after failure of previous PLB, evaluation of abdominal mass or large liver sample for enzymatic analysis (5).

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Conditions studied

  • Percutaneous Liver Biopsy

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03

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 40 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
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients aged less than 18 years

Inclusion criteria

  • All liver biopsy reports taken from infants and children with suspected liver disease aged less than 18 years between January 2019 and December 2023 who had been admitted in Pediatric Gastroenterology and Hepatology unit, Assiut University Children Hospital will be reviewed and included in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients more than 18 years of age. Children with suspected Wilson Disease due to non-availability of the special stains used for histological diagnosis of the disease.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • ProcedurePercutaneous liver biposy

    Percutaneous liver biopsy in pediatric patient diagnostic significance and pattern of liver diseases

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What researchers measure

Primary outcomes

  1. Identification of different patterns of liver diseases (inflammatory, metabolic, biliary abnormalities, cystic diseases of liver, others) and its correlation with clinical presentation.

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, 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
NCT06773390
Lead sponsor
Assiut University
Responsible party
Mohrail nagy naeim kerolos (Assiut government, Assiut University) — Principal investigator
First posted
Jan 14, 2025
Start date
Mar 1, 2025 (estimated)
Primary completion
Jun 28, 2026 (estimated)
Completion
Jul 20, 2026 (estimated)
Last update
Jan 14, 2025

Study contacts

Mohrail nagy Mohrail nagy naeim
Contact
mohrailnagy6@gmail.com
01021975455

Oversight

Data monitoring committee
No
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 Jan 2025. You cannot join it, but the record below documents what was studied.

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