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临床试验/NCT03775811
NCT03775811已完成不适用

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

Hospital Clinic of Barcelona1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Accuracy of the computer-aided system for predicting polyps histology in real clinical practice

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: One year

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana García-Rodríguez

Principal Investigator

Hospital Clinic of Barcelona

研究点 (1)

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