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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

The objective of this observational study is to investigate whether the self-developed whole slide scanning and artificial intelligence diagnostic system for pancreatic solid lesion puncture cytopathology (hereinafter referred to as the "Zhiying Shunxi" ROSE-AI diagnostic system) can promptly and accurately diagnose solid pancreatic lesions (SPLs). The main question it aims to answer is:

By utilizing optical imaging technology to capture RGB images of Diff-Quik stained smears from pancreatic punctures, can the development of artificial intelligence algorithms assist in differentiating solid pancreatic space-occupying diseases (such as pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumors, and non-neoplastic benign lesions)?

Researchers will compare the diagnoses of SPLs made by the ROSE-AI system with the actual pathological diagnoses of the SPLs themselves to determine whether the ROSE-AI system can effectively diagnose SPLs.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ROSE-AI diagnostic system

Treatment groups

1,500 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Ruijin Hospital

Lead sponsor

Second Affiliated Hospital of Soochow University

Collaborator

Fudan University

Collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

The Third Xiangya Hospital of Central South University

Collaborator

Shanghai 10th People's Hospital

Collaborator

Affiliated Hospital of Jiangnan University

Collaborator

Jiangyin People's Hospital

Collaborator