Endoscopic Ultrasound-guided Fine-needle Aspiration of Solid Pancreatic Lesions With Rapid Staining of Cytological Smears Followed by Whole Slide Scanning and Artificial Intelligence Diagnosis: A Prospective, Multicenter Study.

Launched by RUIJIN HOSPITAL · Feb 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new system called "Zhiying Shunxi" ROSE-AI, which uses advanced technology to quickly and accurately identify solid pancreatic lesions. These lesions can be caused by various conditions, including pancreatic cancer and non-cancerous growths. The researchers want to see if this AI system can help doctors distinguish between different types of pancreatic diseases by analyzing images from samples taken during a procedure called endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA).

To participate in this study, individuals must be at least 18 years old and have a diagnosis or suspicion of a solid pancreatic lesion based on imaging tests like ultrasound, CT scans, or MRIs. Participants will undergo the EUS-FNA procedure, during which a small sample of tissue will be taken for testing. The main goal is to compare the AI's diagnosis with traditional pathology results to see how well the AI performs. If you or someone you know is interested and meets the eligibility criteria, it could be an important opportunity to contribute to advancements in pancreatic disease diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A dated and signed informed consent form A commitment to abide by the research procedures and cooperate throughout the entire study Subjects aged 18 and above, regardless of gender Diagnosis or suspicion of a solid pancreatic space-occupying lesion based on imaging studies (B-mode ultrasound, CT, or MRI)
• Exclusion Criteria:
• • Unable or refusing to sign the informed consent form Unable to suspend anticoagulation/antiplatelet therapy Pregnant or lactating Having a mental illness or other medical conditions that are unsuitable for undergoing FNA/B biopsy Presence of coagulation disorders (PLT \< 50 × 10\^3/μl, INR \> 1.5) Pancreatic cystic lesions Non-diagnostic EUS-FNA/B specimens Having less than 8 microscopic fields of interest (ROI) in the digital pathology images of the entire Diff-Quik smear slide