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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-04

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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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

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Myocardial Injury After Non-Cardiac Surgery Ischemia Reperfusion Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Portal vein

The patient will experience and only experience portal vein occlusion during the surgery.

No interventions assigned to this group

Pringle

The patient will experience Pringle occlusion during the surgery.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No