Mechanisms of Macrophage Polarization in HIRI in Patients With NAFLD

April 27, 2025 updated by: Zhifeng Gao

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 102218
        • Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing partial hepatectomy

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
NAFLD group
Other: NAFLD
This study is an observational one with no intervention
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of transaminase
Time Frame: 7 days after the operation
ALT、AST
7 days after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhifeng Gao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

April 27, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25304-4-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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