Development of an Interpretable Prediction Model for Myocardial Injury After Noncardiac Surgery in Patients Undergoing Major Hepatobiliary Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,800
- 试验地点
- 6
- 主要终点
- Incidence of Myocardial Injury After Noncardiac Surgery
研究概览
简要总结
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.
详细描述
Study Design and Methodology: The study consists of four consecutive phases aimed at constructing a robust and interpretable prediction model for MINS.
- Multi-center Cohort Standardization: Based on clinical data from multiple participating centers, the investigators will establish a standardized structural dataset. Strict inclusion and exclusion criteria will be applied. The process involves rigorous data cleaning and normalization to harmonize demographics, surgical operation details, and perioperative hemodynamic parameters across different centers, laying the foundation for model construction.
- Nested Modeling and Performance Evaluation: A nested modeling strategy will be employed to assess the incremental predictive value of specific surgical and biological variables:
Model A (Baseline): Constructed using standard baseline variables such as the Revised Cardiac Risk Index (RCRI).
Model B (+Surgical Technique): Incorporates hepatic inflow occlusion strategies, specifically comparing SPVO (Selective Pringle Vascular Occlusion) vs. Pringle maneuver, along with occlusion duration and frequency.
Model C (Full Model): Further incorporates MINS-related biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •(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.
研究组 & 干预措施
Study Cohort
Adult patients scheduled for major hepatobiliary surgery at Beijing Tsinghua Chang Gung Hospital and other participating centers.
干预措施: Major Hepatobiliary Surgery (Procedure)
结局指标
主要结局
Incidence of Myocardial Injury After Noncardiac Surgery
时间窗: Within 30 days after surgery
MINS is defined as myocardial injury resulting from myocardial ischemia (that may or may not result in necrosis) occurring within 30 days after surgery. The diagnosis is based on a peak high-sensitivity cardiac troponin (hs-cTn) level exceeding the 99th percentile upper reference limit (URL) due to presumed ischemic etiology, irrespective of the presence of ischemic symptoms or electrocardiographic (ECG) changes. Routine hs-cTn screening will be performed on postoperative days 1, 2, and 3. Additional measurements will be taken if clinical signs of ischemia occur anytime within the 30-day follow-up period.
次要结局
- 30-day All-cause Mortality(Within 30 days after surgery)
- Postoperative Length of Hospital Stay(Up to 90 days)
研究者
Zhifeng Gao
Associate Professor
Beijing Tsinghua Chang Gung Hospital