Actively Recruiting
Differential Impact of Pringle Occlusion vs. Portal Vein Occlusion-Induced Liver Ischaemia-Reperfusion Injury on Myocardial Injury Following Noncardiac Surgeries
Led by Beijing Tsinghua Chang Gung Hospital · Updated on 2025-05-15
800
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how liver damage caused by blood flow interruption during major hepato-biliary surgery affects the risk of heart injury after non-cardiac surgeries. This study focuses on patients aged 65 or older, or those 45 and older with heart disease risks. It compares two types of liver blood flow blockage techniques—Pringle occlusion and portal vein occlusion—to understand their impact on myocardial injury after surgery (MINS). The goal is to identify factors that increase MINS risk and improve early detection and prevention. This observational cohort study includes both past and future patients undergoing long major hepato-biliary surgeries requiring ICU care. Participants are grouped by whether they had Pringle occlusion or portal vein occlusion during their surgery. Researchers will collect liver and blood samples from some prospective patients to study the underlying biological mechanisms. Outcomes measured include the occurrence of myocardial injury within three days after surgery, hospital stay length, complications within 30 days, and survival rates at one year. Participants will have their clinical and surgery-related data collected and monitored during and after their surgeries. Follow-up includes checking for heart injury signs shortly after surgery and tracking recovery, complications, and survival over time. The study lasts up to one year post-operation, with detailed assessments helping to understand how liver injury influences heart health. This information aims to help tailor better care for patients undergoing these complex surgeries.
CONDITIONS
Brief Title
Differential Impact of Pringle and Portal Vein Occlusion on Myocardial Injury After Non-Cardiac Surgeries.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older, or 45 years or older 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)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgery
Participants undergo major hepato-biliary surgery with either Pringle or Portal vein occlusion causing liver ischemia-reperfusion injury.
1 surgery visit (in-person)
Duration - 30 days postoperatively
Participants are monitored for myocardial injury and complications after surgery, with sample collection for some participants in the prospective group.
Visits within 3 days post-surgery and additional follow-up visits up to 30 days
Duration - 1 year
Participants are followed for survival and health status up to 1 year after surgery.
Periodic follow-up visits during the year
Trial Site Locations
Total: 1 location
1
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University
Beijing, Beijing Municipality, China, 102218
Actively Recruiting
Research Team
Z
Zhifeng Gao, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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