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OpenTrials
Completed

NCT Number: NCT06279546

Artificial Intelligence vs Endoscopist Identification in EUS Normal Anatomy

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IECED

Guayaquil, Guayas, 090505, Ecuador

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Detection of structures

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.

Primary outcomes

  1. Diagnostic accuracy

    Time frame: 5 months

    The true positive, true negative, false positive and false negative based on detection of anatomical structures according to the an external expert endoscopist as gold-standard.

Secondary outcomes

  1. Interobserver agreement

    Time frame: 5 months

    Comparison of diagnostic accuracies between Artificial intelligence (AI)-based model and both groups (expert and non-expert endoscopists) using Fleiss Kappa.

Sponsors and collaborators

Lead sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Other

Collaborators

  • Barra Life Medical Center, Brazil
  • Baylor Saint Luke's Medical Center
  • Beth Israel Deaconess Medical Center
  • Carol Davila University of Medicine and Pharmacy
  • ELIAS Emergency University Hospital
  • Hospital Civil de Morelia, Michoacan
  • Hospital Clinico Universitario de Santiago
  • Larkin Community Hospital
  • The Methodist Hospital Research Institute
  • Universitair Ziekenhuis Brussel
  • mdconsgroup, Guayaquil, Ecuador

Registry information

Official study title

Comparative Evaluation of Artificial Intelligence and Endoscopists´ Accuracy in Endoscopic Ultrasound for Identifying Normal Anatomical Structures: A Multi-institutional, Cross-sectional Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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