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Prediction Model for MINS After Major Hepatobiliary Surgery

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary endpoint(s) modifiedv2 Show 4 more changesShow less
    • Start date: Jun 11, 2025 to Jan 14, 2026
    • Trial arms changed: 1 → 2
    • Secondary endpoints: 2 to 4
    • Site details revised at 5 of 6 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07335042
Lead Sponsor Beijing Tsinghua Chang Gung Hospital
Conditions
(from sponsor)		 Myocardial Injury After Noncardiac Surgery (MINS), Postoperative Complications, Liver Neoplasm, Hepatobiliary Diseases
Related terms Digestive System Diseases, Liver Neoplasms, Postoperative Complications
Enrollment 1,800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov