Prediction Model for MINS After Major Hepatobiliary Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Major Hepatobiliary Surgery.
- Кому может быть актуально
- Состояния в реестре: Myocardial Injury After Noncardiac Surgery (MINS), Postoperative Complications, Liver Neoplasm, Hepatobiliary Diseases. Базовые параметры: 18 лет — 85 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Development of an Interpretable Prediction Model for Myocardial Injury After Noncardiac Surgery in Patients Undergoing Major Hepatobiliary Surgery
Обзор
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.
Подробное описание
Study Design and Methodology: The study consists of four consecutive phases aimed at constructing a robust and interpretable prediction model for MINS.
1. 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. 2. 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.
Model performance will be comprehensively evaluated using:
Discrimination: Area Under the Receiver Operating Characteristic Curve (AUC).
Calibration: Calibration plots.
Clinical Utility: Net Reclassification Improvement (NRI) and Decision Curve Analysis (DCA) to assess the improvement in risk stratification and clinical net benefit after adding new variables. 3. Model Interpretability Analysis: To enhance the transparency of the model ("White-box" approach), SHAP (SHapley Additive exPlanations) values or similar methods will be utilized. This will quantify and visualize the specific contribution (weight) of key variables, such as SPVO usage, to the individual risk prediction, aligning the statistical results with clinical medical reasoning. 4. External Validation: The final model will undergo validation using an independent external clinical cohort. This step aims to test the stability and generalizability of the model across different center data, defining its applicable scope in real-world clinical scenarios.
Вмешательства
- Процедура Major 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.
Первичные конечные точки
- The area under the receiver operating characteristic curve (AUC) of predictive model [Срок оценки: Within 3 days after surgery]
Вторичные конечные точки (4)
- Model calibration [Срок оценки: Within 3 days after surgery]
- Decision curve analysis (DCA)-derived clinical net benefit [Срок оценки: Within 3 days after surgery]
- Model stability and generalizability in the external validation cohort [Срок оценки: Within 3 days after surgeries]
- Contribution weight of key variables (SPVO, biomarkers) analyzed via SHAP [Срок оценки: Within 3 days after surgeires]
Критерии участия
Критерии включения
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.
Критерии исключения
(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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 6 центров
- Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine,Tsingh — Пекин
- Peking University International Hospital — Пекин
- The First Affiliated Hospital of Army Medical University — Чунцин
- Qingdao West Coast New Area People's Hospital — Qingdao
- The First Affiliated Hospital of Shandong First Medical University — Shandong
- Zhuhai People's Hospital — Zhuhai
Идентификаторы
NCT: NCT07335042 · 26082-4-01