Study on AI-assisted Multimodal Diagnosis System of Autoimmune Pancreatitis

NCT06369909 | Recruiting

• 1 other identifier: K5507
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autoimmune Pancreatitis

Keywords

Autoimmune pancreatitis; Endoscopic ultrasonography; Artificial intelligence; Follicular helper T cells; Klebsiella pneumoniae

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

AIP group

Suspected AIP, pancreatic mass patients who have not initiated steroid hormone therapy

Procedure: EUS-FNA

Control group

Pancreatic mass patients considering malignancy and planning to undergo EUS-FNA

Procedure: EUS-FNA

Interventions

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.

AIP group; Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Tianjin Medical University General Hospital: collaborator
• The Second Hospital of Hebei Medical University: collaborator

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

10 mL of peripheral blood sample, stool sample, fine needle biopsy samples of pancreatic lesions in autoimmune pancreatitis, biopsy samples of duodenal mucosa.

MeSH Terms

Conditions

Autoimmune Pancreatitis

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Pancreatitis, Chronic; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

Xi Wu, M.D.

CONTACT

13683296860; xiwbj@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 17, 2024
• Study Start: January 31, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-04

Locations

CN (1)