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临床试验/NCT06279546
NCT06279546已完成不适用

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

Instituto Ecuatoriano de Enfermedades Digestivas1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Diagnostic accuracy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Internet connection less than 100 MBs per second.
  • Patients with abnormal structures or with visible lesions.

结局指标

主要结局

Diagnostic accuracy

时间窗: 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.

次要结局

  • Interobserver agreement(5 months)

研究者

发起方
Instituto Ecuatoriano de Enfermedades Digestivas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Robles-Medranda

Head of the Endoscopy Division

Instituto Ecuatoriano de Enfermedades Digestivas

研究点 (1)

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