Clinical Trial

Prediction Model for MINS After Major Hepatobiliary Surgery

Recruiting
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Summary
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.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-06-16
minor Trial arms changed: 1 -> 2 2026-06-16
Trial Details
NCT Number NCT07335042
Lead Sponsor Beijing Tsinghua Chang Gung Hospital
Conditions Myocardial Injury After Noncardiac Surgery (MINS), Postoperative Complications, Liver Neoplasm, Hepatobiliary Diseases
Enrollment 1,800 participants
Start Date 2026-01-14
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-15