Fatty LiverNCT07362745
Single-Cell and Spatial Transcriptomics Analysis of Steatotic Donor Liver Susceptibility to Post-Transplant Injury
An observational study of Fatty Liver and Liver Transplant; Complications, run by Xijing Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fatty Liver, Liver Transplant; Complications, Ischaemia Reperfusion Injury of Liver
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hepatobiliary Surgery, Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi, 710032
About this study
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:
Read more
- 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.
- Conditions
- Fatty Liver, Liver Transplant; Complications, Ischaemia Reperfusion Injury of Liver, End Stage Liver Disease, Liver Failure, Postoperative Complications
- Medical subject headings
- Fatty Liver, End Stage Liver Disease, Liver Failure, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Steatotic Donor Liver Recipients | 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. | |
| Normal Donor Liver Recipients | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 10 years post-transplantation, determined by retrospective data availability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jan 2015
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Lin, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362745
- Sponsor's protocol ID
- KY20252571-C-1
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Cell and Spatial Transcriptomics Analysis of Steatotic Donor Liver Susceptibility to Post-Transplant Injury
- ClinicalTrials.gov ID
- NCT07362745
- Acronym / sponsor ID
- KY20252571-C-1
- Conditions
- Fatty Liver, Liver Transplant; Complications, Ischaemia Reperfusion Injury of Liver, End Stage Liver Disease, Liver Failure, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steatotic Donor Liver Recipients | – | –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. |
| Normal Donor Liver Recipients | – | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- 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
- Fatty degeneration range: Macrovesicular steatosis 0-30%
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver and Liver Transplant; Complications, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.