Single-Cell and Spatial Transcriptomics Analysis of Steatotic Donor Liver Susceptibility to Post-Transplant Injury

The goal of this observational study is to understand why liver transplants from donors with fatty liver disease (steatotic donor livers) are more vulnerable to post-transplant injury, analyzing historical clinical data and collected tissue samples using advanced genetic techniques.

The main questions it aims to answer are:

* Which specific cell types and their spatial interactions contribute to increased post-transplant injury susceptibility in steatotic donor livers? * What are the key molecular differences in gene expression between steatotic and normal donor livers following transplantation?

Researchers will compare 300 historical liver transplant cases from 2015-2025, including 50 cases with archived tissue samples available for molecular analysis, and 250 cases with clinical data only. Donor liver steatosis was assessed by histopathology when tissue was available, or by donor clinical data when tissue was not available. The two groups (steatotic donor liver recipients vs. normal donor liver recipients) will be matched based on donor age, ischemia time, recipient scores, and other key clinical parameters to control for potential confounding variables.

This is a retrospective analysis of existing data and archived biospecimens; no prospective participant enrollment or additional sample collection will occur.

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Key information

Conditions

Fatty Liver Digestive System Diseases End Stage Liver Disease Hepatic Insufficiency Ischaemia Reperfusion Injury of Liver Liver Diseases Liver Failure Liver Transplant; Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Hepatobiliary Surgery, Xijing Hospital, Air Force Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Recipient Criteria:

Participant (or legal representative if unable to read/sign) provides written informed consent
Age 18-80 years (inclusive) at time of enrollment
Clinical diagnosis of liver failure requiring liver transplantation
Stable vital signs and deemed medically fit to tolerate liver transplantation surgery

Donor Criteria:

Fatty degeneration range: Macrovesicular steatosis 0-30%
Donor age: ≤60 years
Cold ischemia time (CIT): ≤12 hours for deceased donors
Liver function: ALT/AST <5 times upper limit of normal

Exclusion criteria

Recipient Criteria:

Pregnant or lactating women
Prior history of non-autologous (allogeneic) bone marrow or stem cell transplantation
Blood transfusion within 7 days prior to tissue sampling
Radical cancer treatment within 3 years prior to enrollment
Use of anti-tumor medications within 30 days prior to enrollment
Known bleeding diathesis or coagulation disorder
Active autoimmune disease
Concurrent malignancy or multiple primary tumors

Donor Criteria:

Fibrosis: Any degree of hepatic fibrosis
Steatohepatitis: Presence of lobular inflammation or hepatocyte ballooning
Active infection: HBV, HCV, or HIV positive
Severe fatty liver-related comorbidities: Uncontrolled diabetes (HbA1c>8%), severe hyperlipidemia

Treatment and study plan

Primary outcomes

Differential Expression of Post-Transplant Injury-Related Genes

Time frame: Tissue collection at two intraoperative time points (during graft preparation and before abdominal closure); sequencing and data analysis completed within 1 year of data collection

Quantification of injury-related gene expression changes associated with post-transplant liver injury in liver tissue samples analyzed by single-cell RNA sequencing. Expression levels will be compared between recipients of steatotic donor livers (≥5% macrovesicular steatosis) and recipients of normal donor livers (<5% steatosis) to identify molecular mechanisms underlying increased injury susceptibility.
Postoperative Liver Function Recovery and Clinical Outcomes

Time frame: Up to 10 years post-transplantation, determined by retrospective data availability

Comparison of post-transplant clinical parameters between recipients of steatotic versus normal donor livers, including serial measurements of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and other standard liver function tests, as well as vital signs and clinical assessment data collected during postoperative follow-up.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2026
Study completion: 2026
First posted: Jan 23, 2026
Registry last updated: Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed