Liver Biopsy in Diagnosis Neonatal Jaundice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Neonatal Cholestasis Neonatal Jaundice

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Neonates

Neonates with persistent neonatal jaundice underwent liver biopsy

Group Type EXPERIMENTAL

Liver biopsy

Intervention Type DIAGNOSTIC_TEST

surgical biopsy from liver

Interventions

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Liver biopsy

surgical biopsy from liver

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Liver wedge biopsy Liver core biopsy Liver incisional biopsy

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No