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Completed

NCT Number: NCT06895798

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

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Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine,Tsinghua University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Myocardial injury after non-cardiac surgery (MINS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

Differential Impact of Pringle Occlusion vs. Portal Vein Occlusion-Induced Liver Ischaemia-Reperfusion Injury on Myocardial Injury Following Noncardiac Surgeries.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 26, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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