Endoscopic Ultrasound (EUS) Artificial Intelligence Model for Normal Mediastinal and Abdominal Strictures Assessment

Instituto Ecuatoriano de Enfermedades Digestivas

Status: Unknown

Conditions: Strictures; Anatomic Abnormality; Abdomen; Mediastinum

Treatments: Diagnostic Test: Identification or discharge visualization of mediastinal and abdominal organ/anatomic strictures through Endoscopic ultrasound (EUS) videos by an expert endoscopist; Diagnostic Test: Recognition of mediastinal and abdominal organ/anatomic strictures through Endoscopic ultrasound (EUS) videos using artificial intelligence (AI)

Study type: Observational

Funder types: Other

Identifiers

NCT05151939

IECED-26112021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 1 patient group

Patients with normal mediastinal and abdominal organ/anatomic strictures

Description:

Adult patients with normal mediastinal and abdominal organ/anatomic strictures after imaging test and EUS assessment due to chronic dyspepsia.

Treatment:

Diagnostic Test: Identification or discharge visualization of mediastinal and abdominal organ/anatomic strictures through Endoscopic ultrasound (EUS) videos by an expert endoscopist

Diagnostic Test: Recognition of mediastinal and abdominal organ/anatomic strictures through Endoscopic ultrasound (EUS) videos using artificial intelligence (AI)