RecruitingNot Applicable

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

China236 participantsStarted 2024-09-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.
✕. pregnancy.

What they're measuring

the accuracy, sensitivity and specificity of the ROSE-AI system in identifying malignant/non-malignant ROSE samples

Timeframe: During procedure

Trial details

NCT IDNCT06718725

SponsorQilu Hospital of Shandong University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04

Contact for this trial

Zhen Li

18560086106 qilulizhen@sdu.edu.cn

View on ClinicalTrials.gov More The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node trials