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CompletedNCT03775811Updated Jan 18, 2023

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

An observational study in Colonoscopy, Histology and Computer-aided Diagnosis, sponsored by Hospital Clinic of Barcelona. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Hospital Clinic of Barcelona · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

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

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03

In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's enrollment of 90 is below the median of 300 across 226 observational studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with polyps of any size/morphology, detected in a routine or screening colonoscopy, that are resected endoscopically and recovered for histological analysis will be included.

The images obtained will be used to expand the database.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Interventions

  • OtherAUTOMATED POLYP CLASSIFICATION

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

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What researchers measure

Primary outcomes

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

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

    Time frame: One year

07

Study locations

1 site
  • Hospital Clínic de Barcelona
    Barcelona, 08036, Spain
08

References and documents

Publications

  • Sanchez-Montes C, Sanchez FJ, Bernal J, Cordova H, Lopez-Ceron M, Cuatrecasas M, Rodriguez de Miguel C, Garcia-Rodriguez A, Garces-Duran R, Pellise M, Llach J, Fernandez-Esparrach G. Computer-aided prediction of polyp histology on white light colonoscopy using surface pattern analysis. Endoscopy. 2019 Mar;51(3):261-265. doi: 10.1055/a-0732-5250. Epub 2018 Oct 25. PubMed 30360010 ↗
  • Bernal J, Histace A, Masana M, Angermann Q, Sanchez-Montes C, Rodriguez de Miguel C, Hammami M, Garcia-Rodriguez A, Cordova H, Romain O, Fernandez-Esparrach G, Dray X, Sanchez FJ. GTCreator: a flexible annotation tool for image-based datasets. Int J Comput Assist Radiol Surg. 2019 Feb;14(2):191-201. doi: 10.1007/s11548-018-1864-x. Epub 2018 Sep 25. PubMed 30255462 ↗
  • Byrne MF, Chapados N, Soudan F, Oertel C, Linares Perez M, Kelly R, Iqbal N, Chandelier F, Rex DK. Real-time differentiation of adenomatous and hyperplastic diminutive colorectal polyps during analysis of unaltered videos of standard colonoscopy using a deep learning model. Gut. 2019 Jan;68(1):94-100. doi: 10.1136/gutjnl-2017-314547. Epub 2017 Oct 24. PubMed 29066576 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03775811
Lead sponsor
Hospital Clinic of Barcelona
Collaborators
Instituto de Salud Carlos III
Responsible party
Ana García-Rodríguez (Principal Investigator, Hospital Clinic of Barcelona) — Principal investigator
First posted
Dec 14, 2018
Start date
Jan 1, 2019
Primary completion
Mar 31, 2019
Completion
Dec 31, 2022
Last update
Jan 18, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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