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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03775811
Enrollment
90
Registered
2018-12-14
Start date
2019-01-01
Completion date
2022-12-31
Last updated
2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma Colon Polyp, Artificial Intelligence, Colonoscopy, Colorectal Polyp, Computer-aided Diagnosis, Histology, Hyperplastic Polyp

Brief summary

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.

Detailed description

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).

Interventions

OTHERAUTOMATED POLYP CLASSIFICATION

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

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the computer-aided system for predicting polyps histology in real clinical practiceOne yearThe results of the computer-aided system prediction will be compared with the final pathology report, which is the gold standard

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026