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

NCT06895798 | Recruiting DMC

• 1 other identifier: 25045-4-02-1
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Myocardial injury after non-cardiac surgery (MINS)

  MINS, a high-sensitivity troponin T (hs-cTnT) of 20 to \<65 ng/L with an absolute change of at least 5 ng/L

  Within 3 days after surgery

Study Arms (2)

Portal vein

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

Pringle

The patient will experience Pringle occlusion during the surgery.

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 102218, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens, Liver tissue

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhifeng Gao, MD

CONTACT

+8615801249466; btchgzf@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: March 26, 2025
• Study Start: January 4, 2023
• Primary Completion: October 1, 2025
• Study Completion: April 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

CN (1)