About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
1800
Trial design
Cohort
Prospective
Treatments tested in this trial
Major Hepatobiliary Surgery
Procedure/SurgeryPatients undergo standard major hepatobiliary surgery (e.g., hepatectomy). The specific surgical strategy, including the method of hepatic inflow occlusion (e.g., Pringle maneuver or SPVO), is determined by the attending surgeon based on routine clinical practice and patient condition, not by the study protocol.
Treatment groups
Trial outcomes
Primary outcomes
The area under the receiver operating characteristic curve (AUC) of predictive model
The area under the receiver operating characteristic curve (AUC) for predicting myocardial injury after noncardiac surgery (MINS) in patients undergoing major hepatobiliary surgery
Secondary outcomes
Model calibration
assessed by calibration curve / Hosmer-Lemeshow test
Decision curve analysis (DCA)-derived clinical net benefit
Model stability and generalizability in the external validation cohort
Contribution weight of key variables (SPVO, biomarkers) analyzed via SHAP
Sponsors and contacts
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