RecruitingNCT07335042

Prediction Model for MINS After Major Hepatobiliary Surgery

Development of an Interpretable Prediction Model for Myocardial Injury After Noncardiac Surgery in Patients Undergoing Major Hepatobiliary Surgery

Sponsor

Beijing Tsinghua Chang Gung Hospital

Enrollment

1,800 participants

Start Date

Jun 11, 2025

Study Type

OBSERVATIONAL

Conditions

Postoperative Complications Liver Neoplasm Myocardial Injury After Noncardiac Surgery (MINS)Hepatobiliary Diseases

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is building a prediction model to identify which patients are at risk of a heart injury (called MINS — myocardial injury after noncardiac surgery) after major liver or bile duct surgery. It uses blood tests to measure a heart protein (troponin) before and after surgery. **You may be eligible if...** - You are between 18 and 85 years old - You are undergoing a major hepatobiliary (liver or bile duct) surgery lasting at least 3 hours - Your surgery involves removing three or more liver segments or bile duct reconstruction requiring ICU admission - You have complete pre- and post-surgery heart troponin blood test data available **You may NOT be eligible if...** - You had a heart attack, unstable chest pain, heart failure, or significant kidney disease before surgery - Key information about your surgery is missing from your records Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMajor Hepatobiliary Surgery

Patients 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.