NCT07525765 AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer
| NCT ID | NCT07525765 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Gastrectomy for Gastric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 7,000 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 7,000 participants in total. It began in 2026-04-10 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Age: Patients aged ≥ 18 years. 2. Diagnosis: Histologically confirmed primary gastric cancer. 3. Surgical Procedure: Underwent radical gastrectomy (including proximal, distal, or total gastrectomy). 4. Consent: Provision of written informed consent (required specifically for the prospective phase). 5. Data Completeness: Availability of complete preoperative clinical data and postoperative follow-up records covering at least the first 15 days post-surgery. 6. Oncological History: No history of other primary malignant tumors. Exclusion Criteria: 1. Surgical Type: Patients who underwent non-radical resection or emergency surgery. 2. Data Quality: Missing rate of key data fields exceeds 20%. 3. Preoperative Condition: Presence of severe preoperative infection or organ failure. 4. Follow-up Compliance: Unwillingness to participate in prospective follow-up or inability to complete the follow-up schedule (applicable only to the prospective phase).
Contact & Investigator
Jichao Qin, M.D.
STUDY CHAIR
Zhejiang University
Frequently Asked Questions
Who can join the NCT07525765 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Gastrectomy for Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07525765 currently recruiting?
Yes, NCT07525765 is actively recruiting participants. Contact the research team at 12518934@zju.edu.cn for enrollment information.
Where is the NCT07525765 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07525765 clinical trial?
NCT07525765 is sponsored by First Affiliated Hospital of Zhejiang University. The principal investigator is Jichao Qin, M.D. at Zhejiang University. The trial plans to enroll 7,000 participants.
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