Clinical trial NCT05151939: Endoscopic Ultrasound (EUS) Artificial Intelligence Model for Normal Mediastinal and Abdominal Strictures Assessment
Official title: Endoscopic Ultrasound (EUS) Assessment of Normal Mediastinal and Abdominal Organ/Anatomic Strictures Using a Novel Developed Artificial Intelligence Model
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdomen
Mediastinum
Anatomic Abnormality
Strictures
Keywords: Endoscopic ultrasound
Artificial intelligence
Lead sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with normal mediastinal and abdominal organ/anatomic strictures after imaging test and EUS assessment due to chronic dyspepsia.

Brief summary: Therefore, a high number of procedures is necessary to achieve EUS competency, but interobserver agreement still varies widely. Artificial intelligence (AI) aided recognition of anatomical structures may improve the training process and inter-observer agreement. Robles-Medranda et al. developed an AI model that recognizes normal anatomical structures during linear and radial EUS evaluations. We pursue to design an external validation of our developed AI model, considering an endoscopist expert as the gold standard.

Detailed description: Endoscopic ultrasound (EUS) is a high-skilled procedure with a limited number of facilities available for training. Therefore, a high number of procedures is necessary to achieve competency. However, the agreement between observers varies widely. Artificial intelligence (AI) aided recognition and characterization of anatomical structures may improve the training process while improving the agreement between observers. However, developed EUS-AI models have been explicitly trained or only with disease samples or for detecting abdominal anatomical features.

In other fields as Radiation Oncology, developed AI models have been widely used. They must recognize in unison healthy and disease strictures throughout any part of the human body during the contouring. It avoids unnecessary irradiation of normal tissue. EUS-AI models not trained with healthy samples can cause an increase in false-positive cases during real-life practice. It implies potential overdiagnosis of abnormal/disease strictures. EUS-AI models not trained with samples outside

Using an automated machine learning software, Robles-Medranda et al. have previously developed a convolutional neuronal networks (CNN) AI model that recognizes the anatomical structures during linear and radial EUS evaluations (AI Works, MD Consulting group, Ecuador). To the best of our knowledge, this EUS-AI model is the first trained with EUS videos from patients without pathologies and, thus, with normal mediastinal and abdominal organ/anatomic strictures. In this second stage, we pursue to design an external validation of our developed AI model, considering an endoscopist expert as the gold standard.

Eligibility criteria: Inclusion Criteria:

* Patients with no history of the thorax and abdominal abnormalities confirmed through an imaging test requested for healthcare purposes in the last twelve months (e.g., thorax X-ray and abdominal ultrasound or thorax and abdominal CT)
* Patients who undergo EUS assessment due to chronic dyspepsia.

Exclusion Criteria:

* Morphological alteration on at least one mediastinal and abdominal organ/anatomic strictures documented through any imaging test or EUS.
* Uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with a meaningful impact on cardiac risk assessment (NHYA III/IV);
* Refuse to participate in the study or to sign corresponding informed consent.

Primary outcomes:
measure: Overall accuracy of Endoscopic ultrasound (EUS) artificial intelligence (AI) model for identifying normal mediastinal and abdominal organ/anatomic strictures
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Ecuadorian Institute of Digestive Diseases
state: Guayas
Study officials:
affiliation: Ecuadorian Institute of Digestive Diseases
name: Carlos Robles-Medranda
role: PRINCIPAL_INVESTIGATOR
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