Using AI to Diagnose Solid Pancreatic Lesions
内镜超声穿刺胰腺实性占位细胞涂片快速染色后全玻片扫描及人工智能诊断：一项前瞻性、多中心研究
This study is testing a new AI system to see if it can help doctors better and faster diagnose solid pancreatic lesions during an ultrasound procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT06824909 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and above with a diagnosis or suspicion of solid pancreatic lesions based on imaging studies.
Not a fit: Patients with pancreatic cystic lesions or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnoses of pancreatic diseases, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using AI for diagnostic purposes, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.