Artificial Intelligence vs Endoscopist Identification in EUS Normal Anatomy
NCT ID: NCT06279546
Last Updated: 2024-02-28
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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COMPLETED
30 participants
OBSERVATIONAL
2023-05-01
2024-01-26
Brief Summary
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The investigators therefore aim to compare diagnostic accuracy between artificial intelligence (AI)-based model and the endoscopists when identifying normal anatomical structures in EUS-procedures.
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Detailed Description
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Therefore, detection of normal anatomical structures on a separate basis using an AI-based model, expert and non-expert endoscopists to determine where the AI would be most helpful.
The investigators aim to compare the diagnostic accuracy of the AI-based model with the endoscopists identification of normal anatomical structures in EUS procedures.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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AI-based model
AIWorks-EUS Convolutional Neural Network version 2 (CNNv2) (mdconsgroup, Guayaquil, Ecuador) applied on pre-recorded videos for the detection of normal anatomical structures.
Detection of structures
Pre-recorded videos, cropped according to the different windows (mediastinal, gastric, duodenal) will be analyzed by the AIWorks-EUS model and endoscopists on different times for recognition of the different normal anatomical structures.
Expert endoscopists
Endoscopists with \>190 EUS procedures per year, including 75 pancreatobiliary and mucosal cancer staging procedures each, 40 subepithelial cases; and 50 cases of EUS-fine needle aspiration (FNA) (25 of them being pancreatic cases); following the American Society for Gastrointestinal Endoscopy (ASGE) recommendations.
Detection of structures
Pre-recorded videos, cropped according to the different windows (mediastinal, gastric, duodenal) will be analyzed by the AIWorks-EUS model and endoscopists on different times for recognition of the different normal anatomical structures.
Non-expert endoscopists
Endoscopists with \<190 EUS procedures per year, including 75 pancreatobiliary and mucosal cancer staging procedures each, 40 subepithelial cases; and 50 cases of EUS-FNA (25 of them being pancreatic cases); following the American Society for Gastrointestinal Endoscopy (ASGE) recommendations.
Detection of structures
Pre-recorded videos, cropped according to the different windows (mediastinal, gastric, duodenal) will be analyzed by the AIWorks-EUS model and endoscopists on different times for recognition of the different normal anatomical structures.
Interventions
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Detection of structures
Pre-recorded videos, cropped according to the different windows (mediastinal, gastric, duodenal) will be analyzed by the AIWorks-EUS model and endoscopists on different times for recognition of the different normal anatomical structures.
Eligibility Criteria
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Inclusion Criteria
* Non-expert gastrointestinal endoscopists training for EUS.
* Patients with chronic dyspepsia without other findings.
* Patients with previous CT images or upper digestive endoscopy reporting no other findings.
* Patients requiring EUS for surveillance due to family history of pancreatic cancer without findings on MRI.
Exclusion Criteria
* Patients with abnormal structures or with visible lesions.
18 Years
99 Years
ALL
No
Sponsors
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The Methodist Hospital Research Institute
OTHER
Baylor Saint Luke's Medical Center
UNKNOWN
Beth Israel Deaconess Medical Center
OTHER
Barra Life Medical Center, Brazil
UNKNOWN
Hospital Clinico Universitario de Santiago
OTHER
Universitair Ziekenhuis Brussel
OTHER
Hospital Civil de Morelia, Michoacan
UNKNOWN
ELIAS Emergency University Hospital
OTHER
Larkin Community Hospital
OTHER
Carol Davila University of Medicine and Pharmacy
OTHER
mdconsgroup, Guayaquil, Ecuador
UNKNOWN
Instituto Ecuatoriano de Enfermedades Digestivas
OTHER
Responsible Party
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Carlos Robles-Medranda
Head of the Endoscopy Division
Principal Investigators
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Carlos Robles-Medranda, MD FASGE
Role: PRINCIPAL_INVESTIGATOR
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
Locations
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IECED
Guayaquil, Guayas, Ecuador
Countries
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References
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Han C, Nie C, Shen X, Xu T, Liu J, Ding Z, Hou X. Exploration of an effective training system for the diagnosis of pancreatobiliary diseases with EUS: A prospective study. Endosc Ultrasound. 2020 Sep-Oct;9(5):308-318. doi: 10.4103/eus.eus_47_20.
Cho CM. Training in Endoscopy: Endoscopic Ultrasound. Clin Endosc. 2017 Jul;50(4):340-344. doi: 10.5946/ce.2017.067. Epub 2017 Jul 31.
Finocchiaro M, Cortegoso Valdivia P, Hernansanz A, Marino N, Amram D, Casals A, Menciassi A, Marlicz W, Ciuti G, Koulaouzidis A. Training Simulators for Gastrointestinal Endoscopy: Current and Future Perspectives. Cancers (Basel). 2021 Mar 20;13(6):1427. doi: 10.3390/cancers13061427.
Robles-Medranda C, Baquerizo-Burgos J, Puga-Tejada M, Del Valle R, Mendez JC, Egas-Izquierdo M, Arevalo-Mora M, Cunto D, Alcivar-Vasquez J, Pitanga-Lukashok H, Tabacelia D. Development of convolutional neural network models that recognize normal anatomic structures during real-time radial-array and linear-array EUS (with videos). Gastrointest Endosc. 2024 Feb;99(2):271-279.e2. doi: 10.1016/j.gie.2023.10.028. Epub 2023 Oct 10.
Other Identifiers
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IECED-12345
Identifier Type: -
Identifier Source: org_study_id
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