An Artificial Intelligence System for ROSE of EUS-FNA Sample: a Prospective, Multicenter, Diagnostic Study.
Recruiting now
Conditions studied: The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node
In brief
This is an observational study with a prospective, multicenter, disgnostic design. An artificial intelligence system named ROSE-AI system was developed using cytopathological slide images taken by microscope camera or smartphone of pancreas, bile duct, liver and lymph node, collected retrospectively from patients who underwent EUS-FNA and ROSE, and the performance of ROSE-AI system was validated in the datasets collected prospectively.This study aims to assist endoscopists in conducting rapid on-site cytopathology evaluations during EUS-FNA without the presence of cytopathologists. In addition, the diagnostic field was compared between the cytopathologists and ROSE-AI system, endoscopists with or without ROSE-AI system.
Key facts
- Study ID
- NCT06718725
- Run by
- Qilu Hospital of Shandong University
- People needed
- 236
- Starts
- 2024-09-01
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2024-12-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- the patient age ≥18 years accepted EUS-FNA+ROSE.
- agree to participate in the research and be able to sign written informed consent.
You may not qualify if…
- uncorrectable coagulopathy (PTT >50 seconds or INR >1.5) and/or uncorrectable thrombocytopenia (platelet count <50 × 109 /L).
- patients who were too clinically ill to undergo an EUS examination.
- lesions that were deemed inaccessible for EUS-guided sampling.
- unsuccessful EUS-FNA (e.g., failure to obtain an adequate specimen, patient intolerance, intraoperative accidents, etc.).
- Patients with unqualified ROSE smear.
- Patients who underwent biopsy during EUS-FNA but did not receive a definitive pathological diagnosis or pathological report.
- pregnancy.
Where it is running
- Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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