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The primary objective is to construct a multimodal AI model (Cyst-AI) based on EUS images and clinical data such as imaging features(CT or MRI) and laboratory tests to assist endoscopists in the diagnosis of pancreatic cystic lesions(PCLs), mainly differentiating mucinous from non-mucinous lesions.
The secondary objective is to evaluate the model's effectiveness in risk stratification and clinical management for patients with PCLs.
With the development of medical imaging technology, the detection rate of pancreatic cystic lesions (PCLs) has been increasing notably. Although most cysts are benign, a considerable subset has the potential for malignant transformation. Clinical management is based on diagnosis and risk stratification. For PCLs,different diagnosis and risk stratification lead to entirely different clinical strategies and outcomes, which are closely related to the quality of life, economic burden, and psychological stress of patients. Endoscopic ultrasound (EUS) has played a crucial role in the further differential diagnosis of PCLs. Artificial intelligence (AI) has also shown great potential in clinical diagnosis and management. Thus, we plan to retrospectively collect patients' EUS imaging data, radiological and laboratory tests, and other clinical information to construct a model named Cyst-AI which integrates the function of diagnosis and clinical management, to assist in clinical decision-making.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyst-EUS | Patients before 2026 with EUS pictures of pancreatic cystic lesions or cystoid-material lesions have been included in this cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyst-AI model | Diagnostic Test | The multi-center collected data will be divided into a training set, a validation set, and a test set for developing and testing the cyst-AI model. |
| Measure | Description | Time Frame |
|---|---|---|
| The performance of the diagnostic model in differentiating mucinous from non-mucinous PCLs | The performance of the Cyst-AI diagnostic model will be evaluated using the area under the receiver operating characteristic curve (AUC-ROC), with sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) calculated from the model's predictions on the independent validation dataset. PCLs: pancreatic cystic lesions. | Within 3 months upon completion of the diagnostic model training. |
| The risk stratification performance of the clinical management model for mucinous PCLs | The performance of the Cyst-AI risk stratification model to correctly classify lesions into "low risk", "intermediate risk" and "high risk", will be evaluated using the area under the receiver operating characteristic curve (AUC-ROC), with sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) calculated from the model's predictions on the independent validation dataset. PCLs: pancreatic cystic lesions. | Within 3 months upon completion of the risk stratification model training. |
| Measure | Description | Time Frame |
|---|---|---|
| The performance of the diagnostic model in differentiating specific types of PCLs | The performance of the Cyst-AI diagnostic model will be evaluated using the area under the receiver operating characteristic curve (AUC-ROC), with sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) calculated from the model's predictions on the independent validation dataset. PCLs: pancreatic cystic lesions. |
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Inclusion criteria:
Exclusion criteria:
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The cohort will be selected from several hospitals in China, including Tongji Hospital, Tongji Medical College, HUST.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Cheng | Contact | 86-13986097542 | b.cheng@tjh.tjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430030 | China |
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| Within 3 months upon completion of the diagnostic model training. |
| The clinical management performance of the clinical management model for mucinous PCLs | The performance of the Cyst-AI clinical management model to provide accurate clinical recommendations, will be evaluated using the area under the receiver operating characteristic curve (AUC-ROC), with sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) calculated from the model's predictions on the independent validation dataset. PCLs: pancreatic cystic lesions. | Within 3 months upon completion of the clinical management model training. |
| The performance of the model in assisting endoscopists of different levels in diagnosing and managing PCLs | The performance of the Cyst-AI model in assisting endoscopists will be evaluated using the area under the receiver operating characteristic curve (AUC-ROC), with sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) calculated from the model's predictions on the independent validation dataset. PCLs: pancreatic cystic lesions. | Within 1 months upon completion of the human-machine confrontational crossover study |
| The impact of the model on the decision-making process of endoscopists | Questionnaire for endoscopists after assessment will be used to evaluate the degree of impact. | Within 1 months upon completion of the human-machine confrontational crossover study. |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
|
| ID | Term |
|---|---|
| D000077779 | Pancreatic Intraductal Neoplasms |
| D010192 | Pancreatic Pseudocyst |
| D018293 | Cystadenoma, Serous |
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010181 | Pancreatic Cyst |
| D003560 | Cysts |
| D003537 | Cystadenoma |
| D000236 | Adenoma |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
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