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Prediction Model for MINS After Major Hepatobiliary Surgery

Recruitingn/aAges 18 Years - 85 YearsAllBeijing Tsinghua Chang Gung Hospital
NCT07335042 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This multi-center, prospective observational study aims to develop and validate an interpretable prediction model for Myocardial Injury After Noncardiac Surgery (MINS) in patients undergoing major hepatobiliary surgery. The study adopts a nested modeling strategy, starting with baseline risk factors (e.g., RCRI) and stepwise incorporating hepatic inflow occlusion strategies (specifically comparing SPVO vs. Pringle maneuver) and routine intraoperative biomarkers. The model's performance will be evaluated using AUC, Net Reclassification Improvement (NRI), and Decision Curve Analysis (DCA), followed by interpretability analysis using SHAP values and external validation in an independent cohort.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Major Hepatobiliary Surgery
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Where

6 sites
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University
Beijing, China
Peking University International Hospital
Beijing, China
The First Affiliated Hospital of Army Medical University
Chongqing, China
Qingdao West Coast New Area People's Hospital
Qingdao, China
The First Affiliated Hospital of Shandong First Medical University
Shandong, China
Zhuhai People's Hospital
Zhuhai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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