Clinical trial NCT06895798: Differential Impact of Pringle and Portal Vein Occlusion on Myocardial Injury After Non-Cardiac Surgeries.
Official title: Differential Impact of Pringle Occlusion vs. Portal Vein Occlusion-Induced Liver Ischaemia-Reperfusion Injury on Myocardial Injury Following Noncardiac Surgeries.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Injury After Non-Cardiac Surgery
Ischemia Reperfusion Injury
Keywords: liver ischemia reperfusion injury
Myocardial Injury After Non-Cardiac Surgery
Major Hepato-Biliary Surgery
Pringle occlusion
Portal vein occlusion
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 800
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Myocardial injury after non-cardiac surgery (MINS)
timeFrame: Within 3 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University
state: Beijing
Study officials:
References: