AI-guided decision support for managing pancreatic conditions
A Multicenter Clinical Study on AI-Powered Precision Decision-Making Management for Pancreatic Diseases Using Contrast-Enhanced CT
This project will test an AI tool that reads contrast-enhanced CT scans to help doctors decide whether people with suspected pancreatic disease need surgery, close monitoring, or routine follow-up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07439757 on ClinicalTrials.gov |
What this trial studies
This is a multicenter observational study using an AI deep-learning system to classify contrast-enhanced CT images of patients with suspected pancreatic disease into three care pathways: Intervention, Intensive Surveillance, or Routine Surveillance. The AI classifications are compared with clinicians' decisions and with pathological diagnosis or long-term follow-up as the gold standard. Primary outcomes include AI classification accuracy, the risk of missed malignant lesions, rates of unnecessary surgery, and agreement with standard clinical decision-making. The study also records safety and the real-world clinical utility of following AI-recommended management.
Who should consider this trial
Good fit: Ideal candidates are adults with clinically suspected pancreatic disease who are scheduled for contrast-enhanced CT and can provide informed consent.
Not a fit: Patients with prior pancreatic surgery, contraindications to contrast-enhanced CT, poor-quality images, or other conditions that prevent reliable CT interpretation are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the AI could help doctors detect malignant pancreatic lesions earlier and reduce unnecessary surgeries by improving decision consistency.
How similar studies have performed: Previous retrospective and single-center studies of AI for pancreatic imaging have shown promise for lesion detection and risk stratification, but prospective multicenter validation remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically suspected pancreatic disease. * Scheduled to undergo contrast-enhanced CT. * Signed informed consent form indicating agreement to participate. Exclusion Criteria: * 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. * Unsuitability for participation as determined by the investigator, including but not limited to: pregnancy or lactation, severe psychiatric disorders or cognitive impairment, significant comorbidities that may interfere with study results or patient safety.
Where this trial is running
Shanghai
- Changhai Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Beilei Wang, Doctor
- Email: lilly_wang@126.com
- Phone: +86 13774238083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.