Actively Recruiting
A Multicenter Clinical Study on AI-Powered Precision Decision-Making Management for Pancreatic Diseases Using Contrast-Enhanced CT
Led by Changhai Hospital · Updated on 2026-02-27
2000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
T
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an artificial intelligence (AI) system designed to assist in diagnosing and managing pancreatic diseases using contrast-enhanced CT scans. This study compares the AI's recommendations with those of experienced clinicians to assess the system's accuracy, safety, and usefulness in real clinical settings. The goal is to see if the AI can reliably classify patients, reduce missed malignant lesions, and prevent unnecessary surgeries, ultimately improving decisions for pancreatic conditions. The AI analyzes the CT images to classify patients into three groups: Intervention (for surgery or treatment), Intensive Surveillance (close follow-up), or Routine Surveillance (standard monitoring). Meanwhile, clinicians independently assess the same patients using the same categories. Patients in the Intervention group may undergo surgery or treatment, those in Intensive Surveillance receive personalized high-frequency follow-ups, and those in Routine Surveillance have standard follow-up for at least a year. If abnormalities develop, patients may be reclassified to a more intensive group. Participants undergo contrast-enhanced CT scans with their images analyzed by both AI and clinicians. Researchers track classification accuracy, agreement between AI and clinician decisions, rates of unnecessary surgeries, and missed malignant lesions over one year from the scan date. This helps determine the AI system's clinical value and safety. The study spans from March 2026 to October 2029 and includes adults aged 18 to 80 with suspected pancreatic disease.
CONDITIONS
Brief Title
AI-Powered Precision Decision-Making for Pancreatic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically suspected pancreatic disease
- Scheduled to undergo contrast-enhanced CT
- Signed informed consent form indicating agreement to participate
- Age between 18 and 80 years
You will not qualify if you...
- History of pancreatic surgery
- 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 pregnancy, lactation, severe psychiatric disorders, cognitive impairment, or significant comorbidities that may interfere with study results or patient safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a contrast-enhanced CT scan which is analyzed by an AI system and clinical doctors to classify pancreatic disease status and determine the care plan.
1 visit (in-person)
Duration - At least 1 year
Participants classified as needing surveillance are followed with either personalized intensive surveillance or routine surveillance for at least 1 year to monitor disease status and adjust care if abnormalities arise.
Follow-up visits as recommended based on surveillance category
Duration - Variable depending on clinical care
Participants assessed as needing intervention are recommended for further surgical evaluation or treatment based on clinical assessment.
Visit schedule depends on clinical treatment plan
Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
B
Beilei Wang, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here