Liver Biopsy in Diagnosis Neonatal Jaundice

Not Applicable

Not yet recruiting

• Conditions: Neonatal Cholestasis; Neonatal Jaundice
• Interventions: Diagnostic Test: Liver biopsy

• Registration Number: NCT06628726
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-07
• Last Update Posted: 2024-10-08
• Study Start: 2024-11-01
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neonates	Liver biopsy	Neonates with persistent neonatal jaundice underwent liver biopsy

Primary Outcome Measures

Name	Time	Method
Identification of the key histopathological features in liver biopsy	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 Outcome Measures

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