Predicting heart injury after major liver and biliary surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, prospective observational effort to build and externally validate an interpretable prediction model for Myocardial Injury After Noncardiac Surgery (MINS) in patients undergoing major hepatobiliary operations. The investigators will standardize and harmonize multicenter perioperative datasets, then apply a nested modeling strategy that starts with baseline risk factors (Model A: e.g., RCRI), adds surgical inflow occlusion details (Model B: SPVO vs Pringle, occlusion duration/frequency), and finally incorporates intraoperative biomarkers (Model C). Model performance will be measured by discrimination (AUC), calibration, Net Reclassification Improvement (NRI), and Decision Curve Analysis (DCA), with interpretability explored using SHAP values and external validation in an independent cohort. The goal is a transparent, incremental model that clarifies how surgical technique and biomarkers add to baseline cardiac risk in predicting MINS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Adults (18-85 yr, ASA physical status II-III) undergoing major hepatobiliary surgery were enrolled. Major surgery was defined as duration ≥ 3 h involving hepatectomy (≥ 3 segments) or biliary reconstruction necessitating ICU admission. Eligibility required paired perioperative high-sensitivity cardiac troponin T (hs-cTnT) data and comprehensive documentation of surgical covariates, including surgical approach (laparoscopic vs. open), resection nature (anatomic vs. non-anatomic), number of resected segments, tumor characteristics (size and location), and presence of cirrhosis.

Exclusion Criteria:

(1) preoperative acute myocardial infarction, unstable angina, heart failure, or chronic kidney disease (estimated glomerular filtration rate \< 60 ml/ (min · 1.73 m2); (2) undocumented inflow occlusion strategy; or (3) non-imputable missing covariates.

Where it's running

• Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University
  Beijing, China Recruiting
• Peking University International Hospital
  Beijing, China Recruiting
• The First Affiliated Hospital of Army Medical University
  Chongqing, China Recruiting
• Qingdao West Coast New Area People's Hospital
  Qingdao, China Recruiting
• The First Affiliated Hospital of Shandong First Medical University
  Shandong, China Recruiting
• Zhuhai People's Hospital
  Zhuhai, China Recruiting

Study contacts

• Principal investigator: Zhifeng Gao, MD — Beijing Tsinghua Changgeng Hospital
• Study coordinator: Zhifeng Gao, MD
• Email: gzfa02461@btch.edu.cn
• Phone: +86-15801249466

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.