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
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