Using AI to Diagnose Solid Pancreatic Lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of a self-developed artificial intelligence diagnostic system, known as the ROSE-AI system, in diagnosing solid pancreatic lesions through endoscopic ultrasound-guided fine-needle aspiration. The study will utilize optical imaging technology to capture images of stained cytological smears and compare the AI-generated diagnoses with actual pathological results. By focusing on differentiating various pancreatic diseases, including pancreatic ductal adenocarcinoma and neuroendocrine tumors, the study seeks to improve diagnostic accuracy and speed.

Why it matters

Who can join: the full rules

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

Where it's running

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.