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NCT Number: NCT06628726

Liver Biopsy in Diagnosis Neonatal Jaundice

1. Identification and characterization of histopathological features of liver in cases of PNJ. 2. Assessment of key histological features in liver biopsy as diagnostic parameters in differentiating intra-hepatic and extra-hepatic causes of PNJ. 3. Evaluation of role of liver biopsy as a diagnostic tool in conjunction with clinical and laboratory findings.

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Key information

About this study

Neonatal cholestasis (NC) is described as an early-life defect in bile production or flow that causes the liver to retain biliary substances. Persistent Neonatal Jaundice (PNJ) is the presence of variable degrees of jaundice, choluria and hypocholic or acholic stools for more than 10 days during early months of life. The rate of neonatal cholestasis is estimated to be 1 per 2,500 live births worldwide.

In Egypt, about 20.4% of full-term newborns develop jaundice yearly. Extrahepatic cholestasis(EHC) and intrahepatic cholestasis(IHC) are the two main causes of persistent neonatal jaundice. This division is according to the presence or absence of extrahepatic obstruction to bile flow. Biliary atresia(BA) and idiopathic neonatal hepatitis(INH) are the most frequent etiologies for EHC and IHC respectively.

It is critical to identify the underlying cause of PNJ in order to start the right surgical or medicinal treatment. Early surgical referral is necessary in biliary atresia(BA) to increase success rates. In the case of treatable metabolic diseases, a prompt diagnosis justifies prompt, targeted therapy and a better prognosis.

Despite the development of new diagnostic means and advances in imaging techniques, non-invasive biomarkers and genomic studies, a liver biopsy done at the right time is still an important tool to evaluate and diagnose patients with cholestasis, as it will help to decide the etiology, the prognosis and eventually the treatment of the patient.

The evaluation of liver biopsies in infantile cholestasis disorders is crucial as the histologic features of many of these disorders may overlap and vary with age.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All cases presented with persistent neonatal jaundice in the first year of life in 5 years interval (2019-2023), received at Surgical Pathology Laboratory at Assiut University Hospitals, Egypt.

Exclusion criteria

  • Patients older than one year.
  • Patients who underwent liver biopsy in the same age group but were not diagnosed as Persistent Neonatal Jaundice.
  • Patients with deficient clinical data.

Treatment and study plan

Liver biopsy

Diagnostic Test

surgical biopsy from liver

Other names: Liver wedge biopsy, Liver core biopsy, Liver incisional biopsy

Primary outcomes

  1. Identification of the key histopathological features in liver biopsy

    Time frame: baseline

    Identification of the key histopathological features in liver biopsy that aid in differentiation intra-hepatic and extra-hepatic causes of persistent neonatal jaundice (PNJ).

Secondary outcomes

  1. Evaluation of significance of liver biopsy as a diagnostic tool

    Time frame: baseline

    Evaluation of significance of liver biopsy as a diagnostic tool with clinical and laboratory findings in detection of persistent neonatal jaundice (PNJ) causes.

Study contacts

Contact information is provided by the study sponsor or research team.

Abeer M Refaiy, M.D.

CONTACT

[email protected]

+20118449977

Nourhan H Fouad, MBBCh

CONTACT

[email protected]

+201229788587

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Role of Liver Biopsy As a Diagnostic Tool for Neonatal Jaundice Causes

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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