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Percutaneous Liver BiopsyNCT06773390

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

An observational study of Percutaneous Liver Biopsy, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Percutaneous Liver Biopsy
What is being tested?
Percutaneous liver biposy
Type of treatment
Surgery or procedure
How many people
40 participants
Where
No sites listed yet
Study dates
1 Mar 2025to 20 Jul 2026
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 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: patients aged less than 18 years

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mohrail nagy Mohrail nagy naeim contact

01021975455

mohrailnagy6@gmail.com

About this study

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).

Being tested
Percutaneous liver biposy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous liver biposyProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion28 Jun 2026 (estimated)
  4. Study completion20 Jul 2026 (estimated)

Resources

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-control
Time perspective
Retrospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06773390
Sponsor's protocol ID
Percutaneos liver biopsy
Status last verified
Jan 2025
First submitted
9 Jan 2025
Last updated
14 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Percutaneous Liver Biopsy, 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 1 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 14 Jan 2025. 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 Mohrail nagy Mohrail nagy naeim (01021975455, mohrailnagy6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 Jan 2025.

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