Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628726
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Liver Biopsy in Diagnosis Neonatal Jaundice
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Role of Liver Biopsy As a Diagnostic Tool for Neonatal Jaundice Causes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 2500 live births worldwide
In Egypt about 204 of full-term newborns develop jaundice yearly Extrahepatic cholestasisEHC and intrahepatic cholestasisIHC 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 atresiaBA and idiopathic neonatal hepatitisINH 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 atresiaBA 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
In Egypt about 204 of full-term newborns develop jaundice yearly Extrahepatic cholestasisEHC and intrahepatic cholestasisIHC 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 atresiaBA and idiopathic neonatal hepatitisINH 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 atresiaBA 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None