The First Affiliated Hospital, Zhejiang University School of Medicine Yuhang Campus
Hangzhou, Zhejiang, 330100, China
Location status: Recruiting
NCT Number: NCT07525765
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Hangzhou, Zhejiang, 330100, China
Location status: Recruiting
This study employs a hybrid design, collecting both retrospective and prospective data.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Contact information is provided by the study sponsor or research team.
First Affiliated Hospital of Zhejiang University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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