Predicting heart injury after major liver and biliary surgery

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

We test whether a stepwise prediction model using routine clinical data, the type and timing of liver blood-flow control (SPVO vs Pringle), and simple blood markers can predict heart injury (MINS) after major hepatobiliary surgery in adults.

Quick facts

• Study type: Observational
• Enrollment: 1800 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Beijing Tsinghua Chang Gung Hospital (other)
• Locations: 6 sites (Beijing and 5 other locations)
• Trial ID: NCT07335042 on ClinicalTrials.gov

What this trial studies

This is a multi-center, prospective observational effort to build and externally validate an interpretable prediction model for Myocardial Injury After Noncardiac Surgery (MINS) in patients undergoing major hepatobiliary operations. The investigators will standardize and harmonize multicenter perioperative datasets, then apply a nested modeling strategy that starts with baseline risk factors (Model A: e.g., RCRI), adds surgical inflow occlusion details (Model B: SPVO vs Pringle, occlusion duration/frequency), and finally incorporates intraoperative biomarkers (Model C). Model performance will be measured by discrimination (AUC), calibration, Net Reclassification Improvement (NRI), and Decision Curve Analysis (DCA), with interpretability explored using SHAP values and external validation in an independent cohort. The goal is a transparent, incremental model that clarifies how surgical technique and biomarkers add to baseline cardiac risk in predicting MINS.

Who should consider this trial

Good fit: Adults 18–85 years old with ASA physical status II–III undergoing major hepatobiliary surgery (≥3 segments resected or biliary reconstruction, duration ≥3 hours) who have perioperative high-sensitivity troponin T measurements and documented inflow occlusion strategy.

Not a fit: Patients with recent acute myocardial infarction, unstable angina, heart failure, chronic kidney disease (eGFR <60 ml/min/1.73 m2), undocumented inflow occlusion strategy, or missing key perioperative data are unlikely to benefit from the model.

Why it matters

Potential benefit: If successful, the model could identify patients at higher risk for MINS so care teams can tailor monitoring and protective strategies to reduce heart injury around the time of surgery.

How similar studies have performed: Prior work has combined baseline scores like the RCRI and perioperative troponin to predict MINS, but adding hepatic inflow occlusion technique and intraoperative biomarkers is relatively novel and not yet widely validated.

Eligibility criteria

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) undocumented inflow occlusion strategy; or (3) non-imputable missing covariates.

Where this trial is running

Beijing and 5 other locations

• Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University — Beijing, China (RECRUITING)
• Peking University International Hospital — Beijing, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Army Medical University — Chongqing, China (NOT_YET_RECRUITING)
• Qingdao West Coast New Area People's Hospital — Qingdao, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Shandong First Medical University — Shandong, China (NOT_YET_RECRUITING)
• Zhuhai People's Hospital — Zhuhai, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Zhifeng Gao, MD — Beijing Tsinghua Changgeng Hospital
• Study coordinator: Zhifeng Gao, MD

Conditions: Myocardial Injury After Noncardiac Surgery, Postoperative Complications, Liver Neoplasm, Hepatobiliary Diseases, MINS, Major Hepatobiliary Surgery, Hepatectomy, Hepatic Inflow Occlusion