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| Name | Class |
|---|---|
| Taian City Central Hospital | OTHER |
| Qilu Hospital of Shandong University (Qingdao) | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Liaocheng People's Hospital |
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This is an observational study with a prospective, multicenter, disgnostic design. An artificial intelligence system named ROSE-AI system was developed using cytopathological slide images taken by microscope camera or smartphone of pancreas, bile duct, liver and lymph node, collected retrospectively from patients who underwent EUS-FNA and ROSE, and the performance of ROSE-AI system was validated in the datasets collected prospectively.This study aims to assist endoscopists in conducting rapid on-site cytopathology evaluations during EUS-FNA without the presence of cytopathologists. In addition, the diagnostic field was compared between the cytopathologists and ROSE-AI system, endoscopists with or without ROSE-AI system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing EUS-FNA and ROSE | Patients ≥18 years with pancreatic, bile duct, hepatic, or lymph node lesions accepted EUS-FNA and ROSE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROSE-AI system | Diagnostic Test | The cytopathological slide images of the patients' ROSE samples will be identified by the ROSE-AI system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the accuracy, sensitivity and specificity of the ROSE-AI system in identifying malignant/non-malignant ROSE samples | The primary outcome of the study is to evaluate the performance of the ROSE-AI system in identifying the malignant/non-malignant ROSE samples of pancreatic, bile duct, hepatic and lymph node based on both images taken by microscope camera and smartphone, and comparing the performance between the ROSE-AI system and endoscopists, cytopathologists. | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| comparing the diagnostic performance between endoscopists with ROSE-AI system and without ROSE-AI system | A cross-over human-AI contest using images of the prospective testing dataset will be performed. The diagnostic performance of endoscopists with ROSE-AI system and without ROSE-AI system will be evaluated. | During procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with pancreatic, bile duct, hepatic, or lymph node lesions undergoing EUS-FNA and ROSE from the participating hospitals.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Li | Contact | 18560086106 | qilulizhen@sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| Binzhou People's Hospital | OTHER |
| Binzhou Medical University | OTHER |
| 960th Hospital of PLA | UNKNOWN |
| Yidu Central Hospital of Weifang | UNKNOWN |
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cytopathological slide images from patients who underwent EUS-FNA and ROSE