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RECRUITING
NCT06369909

Study on AI-assisted Multimodal Diagnosis System of Autoimmune Pancreatitis

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Study on AI-assisted Multimodal Diagnosis System of Autoimmune Pancreatitis Based on the Mechanism of Tfh Activation by Intestinal Bacteria and Endosonographic Features

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2024-01-31

Completion Date

2026-01-31

Last Updated

2024-11-25

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China