AI-Powered Precision Decision-Making for Pancreatic Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorChanghai Hospital

About this trial

This multicenter clinical trial evaluates an artificial intelligence (AI) system designed to assist in the diagnosis and management of pancreatic diseases. Using contrast-enhanced CT scans, the study compares the AI's recommendations against the decisions of experienced clinicians to verify the system's accuracy and safety in a real-world setting. Patients are categorized into three management groups: Intervention (surgery/treatment), Intensive Surveillance (close monitoring), or Routine Surveillance (standard follow-up). The primary goal is to determine if the AI system can reliably classify patients, reduce the risk of missing malignant lesions, and prevent unnecessary surgeries, thereby improving clinical decision-making for pancreatic conditions.

Eligibility criteria

Qualifiers

Clinically suspected pancreatic disease.

Scheduled to undergo contrast-enhanced CT.

Signed informed consent form indicating agreement to participate.

Disqualifiers

History of pancreatic surgery.

Contraindications to contrast-enhanced CT, including known hypersensitivity to iodinated contrast media or severe renal/hepatic dysfunction.

Suboptimal image quality affecting diagnosis.

Concurrent participation in another interventional clinical trial.

Trial design

Treatments tested in this trial

  • Diagnosis by Artificial Intelligence model

Treatment groups

2,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Changhai Hospital

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator

The Affiliated People's Hospital of Ningbo University

Collaborator

The Second Affiliated Hospital of Jiaxing University

Collaborator

Shanghai Changzheng Hospital

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

Shengjing Hospital

Collaborator

Shanghai Fourth People's Hospital Tongji University

Collaborator

The First Affiliated Hospital of Medical School of Zhejiang University

Collaborator

Shanghai Fudan University Cancer Center

Collaborator