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| Name | Class |
|---|---|
| Jinhua Municipal Central Hospital | OTHER |
| Second Affiliated Hospital of Nanchang University | OTHER |
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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.
This study employs a hybrid design, collecting both retrospective and prospective data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | ||
| External validation set (conducted by other investigators) | Prospective collected data for final performance evaluation, without interventions |
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| Measure | Description | Time Frame |
|---|---|---|
| predictive performance of the deep learning model for identifying patients at high risk of postoperative bleeding requiring re-operation | 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. | The primary endpoint is the AUC-ROC of the model in predicting postoperative bleeding requiring re-operation within 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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This study includes adults (≥18y) with confirmed primary gastric cancer undergoing elective radical gastrectomy (proximal/distal/total) with D1+/D2 lymphadenectomy at [Center]. The cohort comprises retrospective ([2015.6]-[2026.2]) and prospective ([2026.3]-present) arms. Emergency, palliative, or multi-organ resections are excluded to ensure homogeneity.
The investigators anticipate enrolling 7000 patients. The primary outcome is postoperative hemorrhage requiring surgical re-intervention within 30 days. Estimated incidence is 0.5%-2.0%. To address this class imbalance, the AI model will employ stratified sampling and cost-sensitive learning.This population represents standard candidates for curative surgery in tertiary centers. By excluding extreme cases, the model is optimized for risk stratification in routine elective settings, where early warnings prevent catastrophic outcomes. Prospective data will validate real-time generalizability.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianghao Li, B.S. in Computer Science | Contact | 86+15968774033 | 12518934@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jichao Qin, M.D. | Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine Yuhang Campus | Recruiting | Hangzhou | Zhejiang | 330100 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |