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临床试验/NCT06628726
NCT06628726尚未招募不适用

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

Assiut University0 个研究点目标入组 50 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Identification of the key histopathological features in liver biopsy

研究概览

简要总结

  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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Month 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Identification of the key histopathological features in liver biopsy

时间窗: 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).

次要结局

  • Evaluation of significance of liver biopsy as a diagnostic tool(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nourhan Hassan Fouad Hassan

Doctor

Assiut University

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