NCT06824909 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.
| NCT ID | NCT06824909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Pancreatic Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2024-12-31 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2024-12-31 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Frequently Asked Questions
Who can join the NCT06824909 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06824909 currently recruiting?
Yes, NCT06824909 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ruijin Hospital to inquire about joining.
Where is the NCT06824909 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT06824909 clinical trial?
NCT06824909 is sponsored by Ruijin Hospital. The trial plans to enroll 1,500 participants.