Prediction Model for MINS After Major Hepatobiliary Surgery
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 st
| Condition(s) | Myocardial Injury After Noncardiac Surgery (MINS), Postoperative Complications, Liver Neoplasm, Hepatobiliary Diseases |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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) undo |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Beijing Tsinghua Chang Gung Hospital |
| Locations | Beijing, China; Beijing, China; Chongqing, China; Qingdao, China; Shandong, China; Zhuhai, China |
| Start date | 2025-06-11 |
| NCT ID | NCT07335042 |
| Official listing | https://clinicaltrials.gov/study/NCT07335042 |