Artificial Intelligence vs Endoscopist Identification in EUS Normal Anatomy

NCT ID: NCT06279546

Last Updated: 2024-02-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-01-26

Brief Summary

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Endoscopic ultrasound (EUS) visual impression is operator-dependant and can hinder diagnostic accuracy, especially in less experienced endoscopists. The implementation of artificial intelligence can potentially mitigate operator dependency and interpretation variability, helping or improving the overall accuracy.

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.

Detailed Description

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EUS is an operator dependent procedure where accuracy depends on experience and skills. Nowadays, EUS-training can be achieved by a formal fellowship training in a center for 6-24 months or an informal training through didactic sessions with a short hands-on experience. However, parameters for a correct and complete learning experience measurement are yet to be defined. The implementation of artificial intelligence on EUS can potentially mitigate the operator-dependent variable and improve diagnostic accuracy.

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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Gastrointestinal Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Expert gastrointestinal EUS-endoscopists.
* 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

* Internet connection less than 100 MBs per second.
* Patients with abnormal structures or with visible lesions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Methodist Hospital Research Institute

OTHER

Sponsor Role collaborator

Baylor Saint Luke's Medical Center

UNKNOWN

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Barra Life Medical Center, Brazil

UNKNOWN

Sponsor Role collaborator

Hospital Clinico Universitario de Santiago

OTHER

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role collaborator

Hospital Civil de Morelia, Michoacan

UNKNOWN

Sponsor Role collaborator

ELIAS Emergency University Hospital

OTHER

Sponsor Role collaborator

Larkin Community Hospital

OTHER

Sponsor Role collaborator

Carol Davila University of Medicine and Pharmacy

OTHER

Sponsor Role collaborator

mdconsgroup, Guayaquil, Ecuador

UNKNOWN

Sponsor Role collaborator

Instituto Ecuatoriano de Enfermedades Digestivas

OTHER

Sponsor Role lead

Responsible Party

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Carlos Robles-Medranda

Head of the Endoscopy Division

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Ecuador

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.

Reference Type BACKGROUND
PMID: 32913147 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28783919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33804773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37827432 (View on PubMed)

Other Identifiers

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IECED-12345

Identifier Type: -

Identifier Source: org_study_id

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