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NCT Number: NCT07525765

AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine Yuhang Campus

Hangzhou, Zhejiang, 330100, China

Location status: Recruiting

Location contact

Gastroenterological Surgery

CONTACT

[email protected]

86+0571-87235877

About this study

This study employs a hybrid design, collecting both retrospective and prospective data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. predictive performance of the deep learning model for identifying patients at high risk of postoperative bleeding requiring re-operation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianghao Li, B.S. in Computer Science

CONTACT

[email protected]

86+15968774033

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

  • Jinhua Municipal Central Hospital
  • Second Affiliated Hospital of Nanchang University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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