Prediction Model for MINS After Major Hepatobiliary Surgery
Recruiting now
Conditions studied: Myocardial Injury After Noncardiac Surgery (MINS), Postoperative Complications, Liver Neoplasm, Hepatobiliary Diseases
In brief
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.
Key facts
- Study ID
- NCT07335042
- Run by
- Beijing Tsinghua Chang Gung Hospital
- People needed
- 1800
- Starts
- 2026-01-14
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- (1) preoperative acute myocardial infarction, unstable angina, heart failure, or chronic kidney disease (estimated glomerular filtration rate < 60 ml/ (min · 1.73 m2); (2) undocumented inflow occlusion strategy; or (3) non-imputable missing covariates.
Where it is running
- Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University — Beijing, China (enrolling)
- Peking University International Hospital — Beijing, China (enrolling)
- The First Affiliated Hospital of Army Medical University — Chongqing, China (enrolling)
- Qingdao West Coast New Area People's Hospital — Qingdao, China (enrolling)
- The First Affiliated Hospital of Shandong First Medical University — Shandong, China (enrolling)
- Zhuhai People's Hospital — Zhuhai, China (enrolling)
Full record on ClinicalTrials.gov
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