AI-Powered Precision Decision-Making for Pancreatic Diseases

Sponsor
Changhai Hospital
Study ID
NCT07439757
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Diagnosis by Artificial Intelligence model — DIAGNOSTIC_TEST
    To develop an artificial intelligence-based classification management system for pancreatic diseases, achieving automated and precise classification. Contrast-enhanced CT images from all study subjects will be analyzed by the AI system to generate classification results, categorizing patients into three groups: INTERVENTIOM, INTENSIVE SURVEILLANCE or ROUTINE SURVEILLANCE.

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: AI group
    Diagnosis by Artificial Intelligence model
  • Arm: Clinicians group
    Diagnosis by clinicians

Primary Outcome Measure

Classification accuracy [ Time Frame: From date of contrast-enhanced CT scan to 1 year ]

Central Contacts

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