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.

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Zhifeng Gao, MD; Phone Number: +8615801249466; Email: btchgzf@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102218
      • Recruiting
      • Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University
      • Contact: Zhifeng Gao, MD; Phone Number: +8615801249466; Email: btchgzf@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

As of February 2024, patients ≥ 65 years old, or ≥ 45 years old with cardiovascular risk factors (especially known cardiovascular disease), who have undergone or are scheduled to undergo elective major hepatopancreatobiliary surgery under general anesthesia are being recruited/enrolled.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Portal vein; The patient will experience and only experience portal vein occlusion during the surgery.
Pringle; The patient will experience Pringle occlusion during the surgery.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 22, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: liver ischemia reperfusion injury; Myocardial Injury After Non-Cardiac Surgery; Major Hepato-Biliary Surgery; Pringle occlusion; Portal vein occlusion
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Ischemia; Wounds and Injuries; Reperfusion Injury
• Other Study ID Numbers: 25045-4-02-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No