Study on AI-assisted Multimodal Diagnosis System of Autoimmune Pancreatitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Pancreatitis
• Intervention / Treatment: Procedure: EUS-FNA

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Xi Wu, M.D.; Phone Number: 13683296860; Email: xiwbj@aliyun.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
      • Contact: Mai Li; Phone Number: 13683296860; Email: pumchkyc@126.com
      • Principal Investigator: Xi Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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).

Description

Inclusion Criteria:

• From the beginning of the study to the end of the study, patients with pancreatic solid lesions suspected or diagnosed with AIP were treated at Peking Union Medical College Hospital and related research centers.
• The patients themselves and their families understood and were willing to participate in this study, and signed an informed consent form.
• The diagnosis of AIP must comply with the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Autoimmune Pancreatitis (2022).

Exclusion Criteria:

• Individuals who are not suitable for endoscopic examination, including but not limited to: generally poor condition, severe cardiovascular and pulmonary diseases, and difficulty tolerating the examination, coagulation disorders and those who are deemed unsuitable for endoscopic examination by an endoscopist after a face-to-face consultation.
• Patients or family members are unable to understand the conditions and objectives of this study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AIP group; Suspected AIP, pancreatic mass patients who have not initiated steroid hormone therapy	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.
Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: The Second Hospital of Hebei Medical University; Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: April 6, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Artificial intelligence; Endoscopic ultrasonography; Klebsiella pneumoniae; Follicular helper T cells; Autoimmune pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease Attributes; Pancreatic Diseases; Chronic Disease; Pancreatitis, Chronic; Pancreatitis; Autoimmune Pancreatitis
• Other Study ID Numbers: K5507

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No