Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Proportion of patients with HRS AKI
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Proportion of patients with HRS AKI
Time Frame: up to 3 years
Proportion of patients with HRS AKI who have normal, reversible or permanent injury on renal histopathology
Histopathological changes
Time Frame: up to 3 years
Histopathological changes and their association with clinical parameters
Secondary Outcomes
- 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)
Investigators
Dr. Tiffany Cho-Lam Wong
Clinical Associate Professor
The University of Hong Kong