A Multicenter Observational Study to Develop and Validate a Deep Learning Model for Dynamic Assessment of Postoperative Bleeding Risk to Assist Re-operation Decision-Making in Patients With Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- predictive performance of the deep learning model for identifying patients at high risk of postoperative bleeding requiring re-operation
研究概览
简要总结
The goal of this observational study is to develop and validate a deep learning model to dynamically assess postoperative bleeding risk and assist in decision-making for re-operation in adult patients (≥18 years) diagnosed with primary gastric cancer undergoing radical gastrectomy. The main question[s] it aims to answer [is/are]:
Can an AI model based on perioperative dynamic physiological parameters and precise intraoperative blood loss accurately predict the risk of postoperative bleeding requiring re-operation? Does the application of this AI model improve clinical decision-making (e.g., earlier warning time, optimal intervention timing) and patient outcomes (e.g., mortality, length of stay)? Since there is no comparison group (this is a pure observational study without intervention arms), researchers will not compare different treatment groups. Instead, the investigators will evaluate the model's performance (sensitivity, negative predictive value, AUC, calibration) using retrospective data for training and prospective multi-center data for external validation.
Participants will:
Undergo standard radical gastrectomy and routine postoperative care as per clinical practice (no study-specific interventions).
Have their perioperative data collected, including demographics, medical history, vital signs, laboratory tests (blood gas analysis), surgical details, and precise intraoperative blood loss measurements.
(For prospective participants only) Provide informed consent and complete follow-up assessments up to 30 days post-surgery.
详细描述
This study employs a hybrid design, collecting both retrospective and prospective data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Patients aged ≥ 18 years.
- •Diagnosis: Histologically confirmed primary gastric cancer.
- •Surgical Procedure: Underwent radical gastrectomy (including proximal, distal, or total gastrectomy).
- •Consent: Provision of written informed consent (required specifically for the prospective phase).
- •Data Completeness: Availability of complete preoperative clinical data and postoperative follow-up records covering at least the first 15 days post-surgery.
- •Oncological History: No history of other primary malignant tumors.
排除标准
- •Surgical Type: Patients who underwent non-radical resection or emergency surgery.
- •Data Quality: Missing rate of key data fields exceeds 20%.
- •Preoperative Condition: Presence of severe preoperative infection or organ failure.
- •Follow-up Compliance: Unwillingness to participate in prospective follow-up or inability to complete the follow-up schedule (applicable only to the prospective phase).
研究组 & 干预措施
External validation set (conducted by other investigators)
Prospective collected data for final performance evaluation, without interventions
Training set (led by the Principal Investigator)
The main part of retrospective data for model construction, parameter learning, without interventions
Validation set (led by the Principal Investigator)
The remainder of the retrospective data for hyperparameter tuning to prevent overfitting, without interventions
结局指标
主要结局
predictive performance of the deep learning model for identifying patients at high risk of postoperative bleeding requiring re-operation
时间窗: The primary endpoint is the AUC-ROC of the model in predicting postoperative bleeding requiring re-operation within 30 days after surgery
The Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of the AI model for predicting postoperative bleeding requiring re-operation in the external validation cohort.
次要结局
未报告次要终点