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

Recruiting

• Conditions: Myocardial Injury After Non-Cardiac Surgery; Ischemia Reperfusion Injury

• Registration Number: NCT06895798
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Brief 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.

Study Timeline

• Study Start: 2023-01-04
• Study First Submitted: 2025-03-22
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-03-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-10
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Age ≥ 65 years, or ≥ 45 years with cardiovascular risk factors (especially known cardiovascular disease).
• Undergoing elective major hepatopancreatobiliary surgery under general anesthesia.
• ASA physical status II-III.
• Provide written informed consent to participate in the study (applicable to the prospective cohort).

Exclusion Criteria

• Emergency surgery
• Preoperative diagnosis of myocardial infarction or unstable angina
• Severe hepatic insufficiency (Child-Pugh class C)
• Concomitant severe organ dysfunction (e.g., renal failure, respiratory failure)
• Concomitant active infectious disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial injury after non-cardiac surgery (MINS)	Within 3 days after surgery	MINS, a high-sensitivity troponin T (hs-cTnT) of 20 to \<65 ng/L with an absolute change of at least 5 ng/L

Trial Locations

Locations (1)

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University; 🇨🇳 Beijing, Beijing, China