An Artificial Intelligence System for Rapid Onsite Cytologic Pathology Evaluation（ROSE） of Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) Sample: a Prospective, Multicenter, Diagnostic Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node
- Sponsor
- Qilu Hospital of Shandong University
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- the accuracy, sensitivity and specificity of the ROSE-AI system in identifying malignant/non-malignant ROSE samples
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •the patient age ≥18 years accepted EUS-FNA+ROSE.
- •agree to participate in the research and be able to sign written informed consent.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
the accuracy, sensitivity and specificity of the ROSE-AI system in identifying malignant/non-malignant ROSE samples
Time Frame: During procedure
The primary outcome of the study is to evaluate the performance of the ROSE-AI system in identifying the malignant/non-malignant ROSE samples of pancreatic, bile duct, hepatic and lymph node based on both images taken by microscope camera and smartphone, and comparing the performance between the ROSE-AI system and endoscopists, cytopathologists.
Secondary Outcomes
- comparing the diagnostic performance between endoscopists with ROSE-AI system and without ROSE-AI system(During procedure)