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

NCT07525765 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 7000

Last updated 2026-04-13

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Jinhua Municipal Central Hospital

    collaborator OTHER

  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Jichao Qin, M.D. · Zhejiang University

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-10
Primary Completion
2027-12-31
Completion
2028-01-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07525765 on ClinicalTrials.gov