An Artificial Intelligence System for ROSE of EUS-FNA Sample: a Prospective, Multicenter, Diagnostic Study.
NCT ID: NCT06718725
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
236 participants
OBSERVATIONAL
2024-09-01
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients undergoing EUS-FNA and ROSE
Patients ≥18 years with pancreatic, bile duct, hepatic, or lymph node lesions accepted EUS-FNA and ROSE.
ROSE-AI system
The cytopathological slide images of the patients' ROSE samples will be identified by the ROSE-AI system.
Interventions
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ROSE-AI system
The cytopathological slide images of the patients' ROSE samples will be identified by the ROSE-AI system.
Eligibility Criteria
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Inclusion Criteria
2. agree to participate in the research and be able to sign written informed consent.
Exclusion Criteria
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.
18 Years
ALL
Yes
Sponsors
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Taian City Central Hospital
OTHER
Qilu Hospital of Shandong University (Qingdao)
OTHER
Shandong Provincial Hospital
OTHER_GOV
Liaocheng People's Hospital
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Binzhou People's Hospital
OTHER
Binzhou Medical University
OTHER
960th Hospital of PLA
UNKNOWN
Yidu Central Hospital of Weifang
UNKNOWN
Qilu Hospital of Shandong University
OTHER
Responsible Party
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Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Other Identifiers
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2024SDU-QILU-1
Identifier Type: -
Identifier Source: org_study_id