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临床试验/NCT07300709
NCT07300709尚未招募不适用

Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
试验地点
1
主要终点
Proportion of patients with HRS AKI

研究概览

简要总结

Hepatorenal Syndrome (HRS) is a serious complication that can occur in patients with liver cirrhosis, characterised by kidney dysfunction, or acute kidney failure (AKI). While it has traditionally been thought that HRS affects structurally normal kidneys and is completely reversible with liver transplantation, recent evidence suggests this may not always be the case.

The purpose of this study is to examine the actual structural changes in the kidneys of patients with HRS through tissue biopsy and advanced molecular analysis. This may help us better understand the disease mechanism and potentially improve treatment approaches. We aim to challenge the current understanding that HRS always occurs in structurally normal kidneys and is always reversible after liver transplantation. This study will provide valuable insights into the pathophysiology of HRS and may lead to improved diagnostic and treatment strategies in the future.

This is a 3-year single center prospective, non-randomised, open label study at Queen Mary Hospital, The University of Hong Kong. All consecutive patients accepted on the liver transplant waiting list will be invited to participate. Patient will undergo several procedures related to liver transplant and kidney assessment, and receive liver transplantation and renal biopsy.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient must be able to understand and provide informed consent
  • Age ≥ 18 years of age at time of study entry
  • Accepted for liver transplantation (LT)
  • Fulfill the diagnostic criteria of HRS AKI according to International Club of Ascites (ICA) guidelines
  • 3-month post transplant renal biopsy inclusion criteria:
  • Patient with adequate intraoperative renal biopsy
  • Patient must be able to understand and provide informed consent

排除标准

  • Inability or unwillingness to give written informed consent
  • Patient with known pre-existing renal disease
  • Patient with solitary kidney
  • Re-transplantation
  • ABO-incompatible LT
  • Fail to provide 3-month post transplant renal biopsy
  • 3-month post transplant renal biopsy exclusion criteria:
  • Graft failure after LT
  • Any condition deemed inappropriate by the PI

结局指标

主要结局

Proportion of patients with HRS AKI

时间窗: up to 3 years

Proportion of patients with HRS AKI who have normal, reversible or permanent injury on renal histopathology

Histopathological changes

时间窗: up to 3 years

Histopathological changes and their association with clinical parameters

次要结局

  • Duration of HRS AKI(up to 3 years)
  • Response to standard treatment (Terlipressin and albumin)(up to 3 years)
  • Perioperative morbidity(up to 3 years)
  • Post-transplant renal recovery rates(up to 3 years)
  • Transcriptomic signature differences(up to 3 years)

研究者

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

Dr. Tiffany Cho-Lam Wong

Clinical Associate Professor

The University of Hong Kong

研究点 (1)

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