RecruitingNCT07439757

AI-Powered Precision Decision-Making for Pancreatic Diseases

A Multicenter Clinical Study on AI-Powered Precision Decision-Making Management for Pancreatic Diseases Using Contrast-Enhanced CT


Sponsor

Changhai Hospital

Enrollment

2,000 participants

Start Date

Mar 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • Clinically suspected pancreatic disease.
  • Scheduled to undergo contrast-enhanced CT.
  • Signed informed consent form indicating agreement to participate.

Exclusion Criteria5

  • 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.

Interventions

DIAGNOSTIC_TESTDiagnosis by Artificial Intelligence model

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.


Locations(1)

Changhai Hospital

Shanghai, China

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NCT07439757


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