NCT06895798

Differential Impact of Pringle and Portal Vein Occlusion on Myocardial Injury After Non-Cardiac Surgeries.

Differential Impact of Pringle Occlusion vs. Portal Vein Occlusion-Induced Liver Ischaemia-Reperfusion Injury on Myocardial Injury Following Noncardiac Surgeries.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Beijing Tsinghua Chang Gung Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the impact of hepatic ischemia-reperfusion injury (HIRI) on the incidence of myocardial injury after non-cardiac surgery (MINS) and explore the potential underlying mechanisms. A bidirectional cohort study will be conducted, enrolling patients scheduled for major hepato-biliary surgery. Clinical data, perioperative parameters, and postoperative follow-up data will be systematically collected. The incidence of MINS between patients undergoing Pringle occlusion and portal vein occlusion will be compared, and a multivariate analysis will be performed to identify independent risk factors for MINS, providing a basis for early recognition and prevention of MINS.

Detailed description

This observational cohort study consists of both retrospective and prospective components. The study population includes patients undergoing major hepato-biliary surgery (defined as operative time \> 4 hours and postoperative ICU admission) who are either ≥ 65 years old or ≥ 45 years old with cardiovascular risk factors (especially known cardiovascular disease). The exposed group (Pringle group) consists of patients who experience liver ischemia-reperfusion injury due to Pringle occlusion during surgery. The control group (Portal vein group) consists of patients who experience liver ischemia-reperfusion injury due to Portal vein occlusion. The primary outcome is the incidence of MINS (myocardial injury after non-cardiac surgery) within 3 days postoperatively. Secondary outcomes include postoperative length of hospital stay, incidence of complications within 30 days postoperatively, and 1-year survival rate. Finally, liver and blood samples will be collected from a subset of patients in the prospective LIRI group for pathophysiological mechanism investigation.

Conditions

• Myocardial Injury After Non-Cardiac Surgery
• Ischemia Reperfusion Injury

Timeline

• Start date: 2023-01-04
• Primary completion: 2025-10-01
• Completion: 2026-04-01
• First posted: 2025-03-26
• Last updated: 2025-05-15

Locations

1 site across 1 country: China