Actively Recruiting

Age: 18Years - 90Years
All Genders
NCT07525765

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

Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-04-13

7000

Participants Needed

1

Research Sites

94 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Zhejiang University

Lead Sponsor

J

Jinhua Municipal Central Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Histologically confirmed primary gastric cancer
  • Underwent radical gastrectomy (proximal, distal, or total)
  • Provided written informed consent (for prospective phase)
  • Complete preoperative clinical data and postoperative follow-up records for at least 15 days
  • No history of other primary malignant tumors
Not Eligible

You will not qualify if you...

  • Underwent non-radical resection or emergency surgery
  • Missing key data fields exceeding 20%
  • Severe preoperative infection or organ failure
  • Unwilling or unable to complete prospective follow-up schedule

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Hangzhou, Zhejiang, China, 330100

Actively Recruiting

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Research Team

J

Jianghao Li, B.S. in Computer Science

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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