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

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Beijing Tsinghua Chang Gung Hospital

Status

Enrolling

Conditions

Myocardial Injury After Non-Cardiac Surgery
Ischemia Reperfusion Injury

Study type

Observational

Funder types

Other

Identifiers

NCT06895798
25045-4-02-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

800 participants in 2 patient groups

Portal vein
Description:
The patient will experience and only experience portal vein occlusion during the surgery.
Pringle
Description:
The patient will experience Pringle occlusion during the surgery.

Trial contacts and locations

1

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Central trial contact

Zhifeng Gao, MD

Data sourced from clinicaltrials.gov

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