Actively Recruiting
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.
Led by Ruijin Hospital · Updated on 2025-02-13
1500
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
S
Second Affiliated Hospital of Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to follow study procedures and cooperate throughout the study
- Age 18 years or older, any gender
- Diagnosis or suspicion of a solid pancreatic lesion based on imaging tests such as ultrasound, CT, or MRI
You will not qualify if you...
- Unable or unwilling to sign informed consent
- Unable to stop anticoagulation or antiplatelet therapy
- Pregnant or breastfeeding
- Mental illness or medical conditions unsuitable for fine needle aspiration or biopsy
- Blood clotting disorders (platelet count less than 50 x 10^3/µl, INR greater than 1.5)
- Pancreatic cystic lesions
- Non-diagnostic EUS-FNA/B specimens
- Less than 8 microscopic fields of interest in digital pathology images of the smear slides
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
2
Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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