Mechanisms of Macrophage Polarization in HIRI in Patients With NAFLD

NCT06950710 | Active Not Recruiting

• 1 other identifier: 25304-4-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Ischemia-reperfusion Injury; Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Concentration of transaminase

  ALT、AST

  7 days after the operation

Study Arms (2)

NAFLD group

Other: NAFLD

Control group

Interventions

NAFLD OTHER

This study is an observational one with no intervention

Also known as: Control

NAFLD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing partial hepatectomy

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhifeng Gao: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 30, 2025
• Study Start: April 1, 2025
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (1)