An observational study in Autoimmune Pancreatitis, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Peking Union Medical College Hospital · Observational
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.
752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's planned enrollment of 180 is close to the median of 180 across 277 observational studies indexed under Pancreatitis.
Browse Pancreatitis studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
Suspected AIP, pancreatic mass patients who have not initiated steroid hormone therapy
Procedure: EUS-FNA
Pancreatic mass patients considering malignancy and planning to undergo EUS-FNA
Procedure: EUS-FNA
For patients with pancreatic masses, EUS-FNA is performed to confirm pathological diagnosis, and pancreatic biopsy samples and duodenal mucosal biopsy samples are collected.
Tfh level in blood
The type and level of follicular helper T cells in peripheral blood for each patient
Time frame: 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
Time frame: from enrollment to 3 years
AI-EUS differentiation
The differentiation of EUS graphs by AI system
Time frame: from enrollment to 3 years
Cytokine level in blood
IL-4、IL-21、CXCL13、IgG、IgE level in peripheral blood
Time frame: 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.
Time frame: At the time of enrollment
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Peking Union Medical College Hospital