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OpenTrials
Completed

NCT Number: NCT03775811

In Vivo Computer-aided Prediction of Polyp Histology on White Light Colonoscopy

Our group, prior to the present study, developed a handcrafted predictive model based on the extraction of surface patterns (textons) with a diagnostic accuracy of over 90%24. This method was validated in a small dataset containing only high-quality images.

Artificial intelligence is expected to improve the accuracy of colorectal polyp optical diagnosis. We propose a hybrid approach combining a Deep learning (DL) system with polyp features indicated by clinicians (HybridAI). A pilot in vivo experiment will carried out.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

About this study

Optical diagnosis aims to predict the histology of a polyp based on its endoscopic features. This practice could avoid histopathological analysis and reduce the derived costs. Under this premise, the American Society of Gastrointestinal Endoscopy (ASGE), in its Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) statement, established a diagnostic threshold for real-time endoscopic assessment of diminutive polyps. The rationale for its implementation is that the prevalence of advanced histology in polyps < 5mm is very low (0.5%).

Several studies have demonstrated that optical diagnosis of small polyps is safe and feasible in clinical practice and comparable to the current gold standard, histopathology. However, the accuracy of optical diagnosis has been shown to be insufficient in community-based practices or in non-expert hands and the diagnosis is even more difficult in diminutive polyps < 3 mm in which the discrepancy between the endoscopic and pathological diagnosis is about 15%.

Artificial Intelligence (AI) has emerged as a help tool for polyp characterization.

Aiming to improve optical diagnosis using AI methods, we propose a hybrid approach that combines DL with characteristics of polyps manually indicated by endoscopists (HybridAI).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years
  • Approval of participation in the study. Signature of informed consent
  • Patients with at least one polyp of any size/morphology diagnosed in a routine or screening colonoscopy
  • Endoscopies performed with high definition endoscopes

Exclusion criteria

  • Age <18 years
  • Refusal to participate in the study
  • Polyps partially resected in a previous endoscopy
  • Patients with inflammatory disease
  • Impossibility to wash remains of stool or mucus on the surface of the polyp

Treatment and study plan

AUTOMATED POLYP CLASSIFICATION

Other

COLONIC POLYP HISTOLOGY PREDICTION IN WHITE LIGHT IMAGES COMBINING ARTIFICIAL INTELLIGENCE AND CLINICAL INFORMATION

Primary outcomes

  1. Accuracy of the computer-aided system for predicting polyps histology in real clinical practice

    Time frame: One year

    The results of the computer-aided system prediction will be compared with the final pathology report, which is the gold standard

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2022
First posted
Dec 14, 2018
Registry last updated
Jan 18, 2023

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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