Clinical trial NCT06718725: An Artificial Intelligence System for ROSE of EUS-FNA Sample: a Prospective, Multicenter, Diagnostic Study.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Taian City Central Hospital
name: Qilu Hospital of Shandong University (Qingdao)
name: Shandong Provincial Hospital
name: Liaocheng People's Hospital
name: The Affiliated Hospital of Qingdao University
name: Binzhou People's Hospital
name: Binzhou Medical University
name: 960th Hospital of PLA
name: Yidu Central Hospital of Weifang
First posted: 2024-12-05
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with pancreatic, bile duct, hepatic, or lymph node lesions undergoing EUS-FNA and ROSE from the participating hospitals.

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.


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.

Primary outcomes:
measure: the accuracy, sensitivity and specificity of the ROSE-AI system in identifying malignant/non-malignant ROSE samples
timeFrame: During procedure
Secondary outcomes:
measure: comparing the diagnostic performance between endoscopists with ROSE-AI system and without ROSE-AI system
timeFrame: During procedure
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References: