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| Name | Class |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| The Affiliated People's Hospital of Ningbo University | OTHER_GOV |
| The Second Affiliated Hospital of Jiaxing University | OTHER |
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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.
MEHTOD: This multicenter clinical trial evaluates the reliability and effectiveness of an AI system for patients with pancreatic diseases in a real-world clinical environment. The study calculates the AI system's classification accuracy using pathological diagnosis (biopsy/surgery results) or long-term follow-up as the "gold standard" for comparison. Additionally, the safety and clinical utility of the management strategies recommended by the AI are assessed by measuring the risk of missing malignant lesions, the rate of unnecessary surgeries for pancreatic diseases, and the level of agreement with traditional clinical decisions.
STUDY DESIGN
All contrast-enhanced CT images from patients with pancreatic diseases are analyzed by the AI system to generate a classification result (Intervention, Intensive Surveillance, or Routine Surveillance). Simultaneously, clinical doctors review the same data and categorize patients into these three groups to determine their actual care plan:
OUTCOMES: The study compares the performance of the AI system against clinical doctors regarding classification accuracy, the risk of missed diagnoses, unnecessary surgery rates, and decision consistency. These metrics are used to validate the AI system's value, safety, and utility in the clinical management of pancreatic diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI group | Diagnosis by Artificial Intelligence model |
| |
| Clinicians group | Diagnosis by clinicians |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Classification accuracy | The percentage of cases correctly classified by AI out of the total number of cases. | From date of contrast-enhanced CT scan to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement rate with clinical decisions | The proportion of total cases where AI and clinician classification results are in agreement. | From date of contrast-enhanced CT scan to 1 year |
| Percentage decrease in unnecessary surgical procedures |
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Inclusion Criteria:
Exclusion Criteria:
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The study enrolls patients with clinically suspected pancreatic disease who have available contrast-enhanced CT scans and provide informed consent. Patients are excluded if they have a history of pancreatic surgery, contraindications to contrast media, suboptimal image quality, or other conditions deemed unsuitable by the investigator (e.g., pregnancy, cognitive impairment, or concurrent trial participation).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beilei Wang, Doctor | Contact | +86 13774238083 | lilly_wang@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | 200433 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000077779 | Pancreatic Intraductal Neoplasms |
| D050500 | Pancreatitis, Chronic |
| D007516 | Adenoma, Islet Cell |
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Shanghai Changzheng Hospital | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shengjing Hospital | OTHER |
| Shanghai Fourth People's Hospital Tongji University | OTHER |
| The First Affiliated Hospital of Medical School of Zhejiang University | UNKNOWN |
| Shanghai Fudan University Cancer Center | UNKNOWN |
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The percentage reduction in the unnecessary surgery rate achieved by AI decision-making compared to traditional decision-making.
| From date of contrast-enhanced CT scan to 1 year |
| Malignancy miss rate | The proportion of cases classified by AI as non-surgical that actually required surgery. | From date of contrast-enhanced CT scan to 1 year |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000236 | Adenoma |