NCT07525765Recruiting
AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 7000 (estimated)
- First submitted
- 10 Mar 2026
- Start date
- Apr 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07525765
What you commit to
- Study type: Observational
- Planned participants: 7000
- From Apr 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical Type: Patients who underwent non-radical resection or emergency surgery.
Other illness
- Preoperative Condition: Presence of severe preoperative infection or organ failure.
Other
- Data Quality: Missing rate of key data fields exceeds 20%.
- Follow-up Compliance: Unwillingness to participate in prospective follow-up or inability to complete the follow-up schedule (applicable only to the prospective phase).
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine Yuhang Campus Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.