Liver Biopsy in Diagnosis Neonatal Jaundice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liver biopsy.
- Who it may be relevant to
- Registry conditions: Neonatal Cholestasis, Neonatal Jaundice. Basic parameters: 1 months — 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Role of Liver Biopsy As a Diagnostic Tool for Neonatal Jaundice Causes
Overview
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.
Interventions
- Diagnostic test Liver biopsy
surgical biopsy from liver
Primary outcome measures
- Identification of the key histopathological features in liver biopsy [Time frame: baseline]
Secondary outcome measures (1)
- Evaluation of significance of liver biopsy as a diagnostic tool [Time frame: baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Mansour E, Eissa AN, Nofal LM, Kharboush I, Reda AA. Morbidity and mortality of low-birth-weight infants in Egypt. East Mediterr Health J. 2005 Jul;11(4):723-31. PMID 16700389
- Fawaz R, Baumann U, Ekong U, Fischler B, Hadzic N, Mack CL, McLin VA, Molleston JP, Neimark E, Ng VL, Karpen SJ. Guideline for the Evaluation of Cholestatic Jaundice in Infants: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr PMID 27429428
- Ali KM, Zalata KR, Barakat T, Elzeiny SM. Pathologic approach to Neonatal cholestasis with a simple scoring system for biliary atresia. Virchows Arch. 2024 Jan;484(1):93-102. doi: 10.1007/s00428-023-03704-5. Epub 2023 Nov 27. PMID 38008855
Identifiers
NCT: NCT06628726 · biopsy role neonatal jaundice