Gastrectomy Clinical Trials

Clinical trials related to Gastrectomy Procedure

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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital, Zhejiang University School of Medicine Yuhang Campus
RECRUITING
Hangzhou
Contact Information
Primary
Jianghao Li, B.S. in Computer Science
12518934@zju.edu.cn
86+15968774033
Time Frame
Start Date: 2026-04-10
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 7000
Treatments
Training set (led by the Principal Investigator)
The main part of retrospective data for model construction, parameter learning, without interventions
Validation set (led by the Principal Investigator)
The remainder of the retrospective data for hyperparameter tuning to prevent overfitting, without interventions
External validation set (conducted by other investigators)
Prospective collected data for final performance evaluation, without interventions
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Zhejiang University
Collaborators: Jinhua Municipal Central Hospital, Second Affiliated Hospital of Nanchang University

This content was sourced from clinicaltrials.gov