Hepatic Ischemia-reperfusion InjuryNCT06950710
Mechanisms of Macrophage Polarization in HIRI in Patients With NAFLD
An observational study of Hepatic Ischemia-reperfusion Injury and Non-alcoholic Fatty Liver Disease, run by Zhifeng Gao at 1 site in China.
Trial summary
To better understand the occurrence of hepatic ischemia-reperfusion injury (IRI) in patients with non-alcoholic fatty liver disease (NAFLD) and the role of macrophage polarization in this process, this study will retrospectively collect clinical data from patients who underwent partial hepatectomy at Beijing Tsinghua… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Ischemia-reperfusion Injury, Non-alcoholic Fatty Liver Disease
- What is being tested?
- NAFLD
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing partial hepatectomy
Who may be able to join
- The vital organ systems (heart, lungs and kidneys) have sufficient functional reserves.
Who cannot join
- No hepatic inflow occlusion (Pringle maneuver) was applied during surgery.
- American Society of Anesthesiologists (ASA) Physical Status Classification > Grade III.
- Secondary causes of hepatic steatosis were excluded, including viral hepatitis, drug-induced liver injury, total parenteral nutrition, Wilson's disease, and autoimmune liver diseases.
- Prior chemotherapy or radiotherapy before the planned surgery.
- Use of anticoagulant medications.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University
Beijing, Beijing Municipality, 102218
About this study
Official title: Mechanisms of Macrophage Polarization in Hepatic Ischemia-Reperfusion Injury in Patients With Non-Alcoholic Fatty Liver Disease
To better understand the occurrence of hepatic ischemia-reperfusion injury (IRI) in patients with non-alcoholic fatty liver disease (NAFLD) and the role of macrophage polarization in this process, this study will retrospectively collect clinical data from patients who underwent partial hepatectomy at Beijing Tsinghua Changgung Hospital between September 2021 and March 2025. Additionally, clinical information and liver blood samples from patients scheduled for partial hepatectomy from April 2025 onward will be prospectively collected. These samples will include normal liver tissue from the resected portion, as well as 5 mL of venous blood obtained before and after surgery. The investigators will compare the severity of hepatic IRI, the expression of macrophage polarization-related proteins, and macrophage polarization markers in blood samples between NAFLD patients and controls. The study aims to determine whether NAFLD patients experience more severe hepatic IRI and to elucidate the role and mechanisms of macrophage polarization in this context. The findings will provide a theoretical basis for understanding the molecular mechanisms underlying hepatic IRI in NAFLD patients, thereby identifying potential therapeutic targets to prevent IRI and improve prognosis in NAFLD patients undergoing partial hepatectomy.
- Being tested
- NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAFLDOther
Also called Control
This study is an observational one with no intervention
| Study group | Role | What they receive |
|---|---|---|
| NAFLD group | Not described Receives: Other: NAFLD | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of transaminase
ALT、AST
Measured: 7 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Apr 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Ischemia-reperfusion InjuryStudies 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
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhifeng Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhifeng Gao, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950710
- Sponsor's protocol ID
- 25304-4-01
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Macrophage Polarization in Hepatic Ischemia-Reperfusion Injury in Patients With Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06950710
- Acronym / sponsor ID
- 25304-4-01
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhifeng GaoUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Apr 2025 (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.
To better understand the occurrence of hepatic ischemia-reperfusion injury (IRI) in patients with non-alcoholic fatty liver disease (NAFLD) and the role of macrophage polarization in this process, this study will retrospectively collect clinical data from patients who underwent partial hepatectomy at Beijing Tsinghua Changgung Hospital between September 2021 and March 2025. Additionally, clinical information and liver blood samples from patients scheduled for partial hepatectomy from April 2025 onward will be prospectively collected. These samples will include normal liver tissue from the resected portion, as well as 5 mL of venous blood obtained before and after surgery. The investigators will compare the severity of hepatic IRI, the expression of macrophage polarization-related proteins, and macrophage polarization markers in blood samples between NAFLD patients and controls. The study aims to determine whether NAFLD patients experience more severe hepatic IRI and to elucidate the role and mechanisms of macrophage polarization in this context. The findings will provide a theoretical basis for understanding the molecular mechanisms underlying hepatic IRI in NAFLD patients, thereby identifying potential therapeutic targets to prevent IRI and improve prognosis in NAFLD patients undergoing partial hepatectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFLD group | – | Other: NAFLD |
| Control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing partial hepatectomy
Key inclusion criteria (1 listed)
- The vital organ systems (heart, lungs and kidneys) have sufficient functional reserves.
Key exclusion criteria (5 listed)
- No hepatic inflow occlusion (Pringle maneuver) was applied during surgery.
- American Society of Anesthesiologists (ASA) Physical Status Classification > Grade III.
- Secondary causes of hepatic steatosis were excluded, including viral hepatitis, drug-induced liver injury, total parenteral nutrition, Wilson's disease, and autoimmune liver diseases.
- Prior chemotherapy or radiotherapy before the planned surgery.
- Use of anticoagulant medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAFLDAlso: ControlThis study is an observational one with no intervention | Other | NAFLD group |
Primary outcome
Concentration of transaminase
Time frame: 7 days after the operation
ALT、AST
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatic Ischemia-reperfusion Injury
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Hypothermic Machine Perfusion for Liver Graft Preservation
Liver Transplant, Liver Failure
Active, not recruitingPhase 4
Dexmedetomidine to Prevent Hepatic Ischemia-reperfusion Injury-induced Glycocalyx Degradation and Early Allograft Dysfunction in Liver Transplantation
Liver Transplant; Complications
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 Hepatic Ischemia-reperfusion Injury and Non-alcoholic Fatty Liver Disease, run by Zhifeng Gao 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 1 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Concentration of transaminase (time frame: 7 days after the operation). 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 30 Apr 2025.