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| Name | Class |
|---|---|
| Tianjin Medical University General Hospital | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
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The existing comprehensive diagnostic system for autoimmune pancreatitis (AIP) is complex, with multidimensional clinical information including morphological changes and a lack of specific biomarkers. Endoscopic ultrasound (EUS) can provide all the elements for morphological diagnosis of AIP, but the long learning curve and large observer differences make it difficult to popularize and promote. The cooperation units of the three regions in this project have found in the early stage that Klebsiella pneumoniae (KP) induced follicular helper T cells (Tfh) activation is an important mechanism of AIP, but the identification of pathogenic components of the strain and clinical validation need to be explored. We have established a national multicenter AIP queue in the early stage and extracted EUS audio-visual features to establish a scoring model, but intelligent assistance is still needed to improve efficiency. Therefore, we plan to integrate gut microbiota, Tfh activation markers, and EUS imaging features to establish an AI assisted multimodal diagnostic system for AIP. This study will collaborate across multiple centers to identify and validate the components that induce Tfh activation in KP bacterial cells, to extract EUS pancreatic ultrasound features and optimize artificial intelligence assisted diagnostic algorithms, and to establish and validate an artificial intelligence assisted multimodal diagnostic system based on clinical information, biomarkers, and EUS. The aim of this study is to provide new diagnosis and treatment evaluation methods for AIP with high accuracy, convenience, and easy promotion for clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIP group | Suspected AIP, pancreatic mass patients who have not initiated steroid hormone therapy |
| |
| Control group | Pancreatic mass patients considering malignancy and planning to undergo EUS-FNA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-FNA | Procedure | For patients with pancreatic masses, EUS-FNA is performed to confirm pathological diagnosis, and pancreatic biopsy samples and duodenal mucosal biopsy samples are collected. |
| Measure | Description | Time Frame |
|---|---|---|
| Tfh level in blood | The type and level of follicular helper T cells in peripheral blood for each patient | from enrollment to 3 years |
| Microbiota composition measured by 16S rRNA sequencing | The gut microbiota of fecal samples and the intestinal microbiota of duodenal biopsy samples using 16S rRNA sequencing for each patient | from enrollment to 3 years |
| AI-EUS differentiation | The differentiation of EUS graphs by AI system | from enrollment to 3 years |
| Cytokine level in blood | IL-4、IL-21、CXCL13、IgG、IgE level in peripheral blood | from enrollment to 3 years |
| Single cell sequencing | Single cell sequencing results of pancreatic lesion biopsy samples and duodenal mucosal biopsy samples in autoimmune pancreatitis. | At the time of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with pancreatic solid lesions suspected or diagnosed with AIP. The diagnosis of AIP must comply with the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Autoimmune Pancreatitis (2022).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Wu, M.D. | Contact | 13683296860 | xiwbj@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D000081012 | Autoimmune Pancreatitis |
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D061765 | Endoscopic Ultrasound-Guided Fine Needle Aspiration |
| ID | Term |
|---|---|
| D044963 | Biopsy, Fine-Needle |
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
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10 mL of peripheral blood sample, stool sample, fine needle biopsy samples of pancreatic lesions in autoimmune pancreatitis, biopsy samples of duodenal mucosa.
| D001327 |
| Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003584 |
| Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061705 | Image-Guided Biopsy |
| D013048 | Specimen Handling |
| D018084 | Ultrasonography, Interventional |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |