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Active, not recruitingNCT06950710Updated Apr 30, 2025

Mechanisms of Macrophage Polarization in HIRI in Patients With NAFLD

An observational study in Hepatic Ischemia-reperfusion Injury and Non-alcoholic Fatty Liver Disease, sponsored by Zhifeng Gao. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by Zhifeng Gao · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Hepatic Ischemia-reperfusion Injury
  • Non-alcoholic Fatty Liver Disease
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In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 300 is above the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

This is the only study on the registry with Zhifeng Gao as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing partial hepatectomy

Inclusion criteria

  • The vital organ systems (heart, lungs and kidneys) have sufficient functional reserves.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • NAFLD group

    Other: NAFLD

  • Control group

Interventions

  • OtherNAFLD

    This study is an observational one with no intervention

    Also known as: Control

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What researchers measure

Primary outcomes

  1. Concentration of transaminase

    ALT、AST

    Time frame: 7 days after the operation

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Study locations

1 site
  • Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine,Tsinghua University
    Beijing, Beijing 102218, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06950710
Lead sponsor
Zhifeng Gao
Responsible party
Zhifeng Gao (Chief Physician, Beijing Tsinghua Chang Gung Hospital) — Sponsor-investigator
First posted
Apr 30, 2025
Start date
Apr 1, 2025
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Apr 30, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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