An Artificial Intelligence System for ROSE of EUS-FNA Sample: a Prospective, Multicenter, Diagnostic Study.

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Dec 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new artificial intelligence system called ROSE-AI, which is designed to help doctors quickly evaluate tissue samples taken from patients during a procedure called EUS-FNA. This procedure involves using a thin needle to collect samples from areas like the pancreas, bile duct, liver, and lymph nodes. The goal of this study is to see if the ROSE-AI system can provide accurate results as effectively as a human expert, allowing doctors to make faster decisions during the examination without needing to wait for a lab report.

To participate in this trial, you need to be at least 18 years old and willing to give your consent to join the study. However, some people may not be eligible, such as those with certain bleeding disorders, serious health issues that make the procedure unsafe, or those who are pregnant. If you join, you can expect to undergo the EUS-FNA procedure, and your samples will be evaluated both by the ROSE-AI system and by experienced pathologists. This study is currently recruiting participants, and it aims to improve the way doctors diagnose conditions related to these organs.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. the patient age ≥18 years accepted EUS-FNA+ROSE.
• • 2. agree to participate in the research and be able to sign written informed consent.
• Exclusion Criteria:
• • 1. uncorrectable coagulopathy (PTT \>50 seconds or INR \>1.5) and/or uncorrectable thrombocytopenia (platelet count \<50 × 109 /L).
• • 2. patients who were too clinically ill to undergo an EUS examination.
• • 3. lesions that were deemed inaccessible for EUS-guided sampling.
• • 4. unsuccessful EUS-FNA (e.g., failure to obtain an adequate specimen, patient intolerance, intraoperative accidents, etc.).
• • 5. Patients with unqualified ROSE smear.
• • 6. Patients who underwent biopsy during EUS-FNA but did not receive a definitive pathological diagnosis or pathological report.
• • 7. pregnancy.