An observational study in Fatty Liver, Liver Transplant; Complications and Ischaemia Reperfusion Injury of Liver, sponsored by Xijing Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Xijing Hospital · Observational
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:
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.
1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.
This study's enrollment of 300 is above the median of 140 across 397 observational studies indexed under Fatty Liver.
Browse Fatty Liver studies →Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
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This retrospective, single-center observational cohort study will enroll 300 adult liver transplant recipients at the First Affiliated Hospital of Air Force Medical University. The study population consists of patients aged 18-80 years with end-stage liver disease requiring orthotopic liver transplantation. Participants will be naturally grouped based on donor liver characteristics into: (1) steatotic donor liver recipients (donor livers with macrovesicular steatosis ≥5%), and (2) normal donor liver recipients (donor livers with steatosis \<5%). All participants must have stable vital signs and be medically fit to tolerate liver transplantation surgery. 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.
Recipient Criteria:
Donor Criteria:
Exclusion Criteria:
Recipient Criteria:
Donor Criteria:
Liver transplant recipients receiving donor livers with macrovesicular steatosis ≥5% (steatotic donor liver). Participants undergo standard liver transplantation with two small liver tissue samples collected during surgery (during graft preparation and before abdominal closure) followed by postoperative monitoring.
Liver transplant recipients receiving donor livers with \<5% steatosis (normal donor liver). Participants undergo standard liver transplantation with two small liver tissue samples collected during surgery (during graft preparation and before abdominal closure) followed by postoperative monitoring.
Differential Expression of Post-Transplant Injury-Related Genes
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.
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
Postoperative Liver Function Recovery and Clinical Outcomes
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.
Time frame: Up to 10 years post-transplantation, determined by retrospective data availability
Plan to share: No — \*\*Plan to Share IPD (Individual Participant Data): No\*\* \*\*Rationale:\*\* This study involves highly sensitive personal data including genomic/transcriptomic information (single-cell and spatial transcriptomics) and detailed clinical records from human transplant recipients. Due to privacy protection requirements, Chinese regulations on human genetic data, and the need for explicit participant consent for data sharing beyond the original research purpose, individual participant data will not be shared publicly. Aggregated, de-identified results will be published in scientific reports.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Xijing Hospital