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临床试验/NCT05261932
NCT05261932Unknown不适用

Research on Endoscopic Precision Biopsy Guided by AI System

Beijing Tsinghua Chang Gung Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年11月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
The accuracy of expert with or without AI

研究概览

简要总结

Colorectal adenoma is a common disease and frequently-occurring disease in gastroenterology. With the continuous progress of colonoscopy equipment and the gradual improvement of endoscopic accessories, especially the development of chromo-endoscopy and magnifying endoscopy. The observation of the surface structure and capillary morphology of colorectal adenomas can realize optical biopsy. Currently, most clinical endoscopic diagnosis of colorectal diseases is biopsy under colonoscopy, and further treatment options are determined based on the pathological results of the biopsy. The problem is that the pathological diagnosis of some preoperative biopsy is not completely consistent with the pathological diagnosis of postoperative large specimens. Previous studies have found that the pathological diagnosis accuracy rate of preoperative biopsy is only 66-75%, so there is a certain degree of subjectivity in relying solely on colonoscopy white light biopsy. Based on the previous work, the research team has initially established an intelligent recognition model for colorectal adenoma classification (low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia), and formed a colorectal adenoma of a certain size with annotated endoscopic image data set. Using the YOLO-V4 algorithm, under the Darknet framework, to train an artificial intelligence (AI) system which specifically for adenoma recognition and diagnosis, its accuracy rate has reached more than 90%. This study intends to increase the sample size based on the previous work, and further improve the accuracy of the classification and diagnosis of the AI system, so as to guide the endoscopist to perform targeted biopsy and improve the accuracy of preoperative biopsy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 30-75;
  • Those who have no mental abnormality and can conduct questionnaire surveys;
  • BBPS ≥ 6;
  • Colorectal advanced adenoma, and admitted for complete resection with EMR and ESD;
  • Provide the relevant information required by this study and sign the informed consent.

排除标准

  • Those who cannot provide the relevant information required by this research;
  • Patients with inflammatory bowel disease;
  • Those with a history of liver cirrhosis, uncontrolled hypertension, history of myocardial infarction, cardiac insufficiency, renal insufficiency, respiratory failure, diabetic ketosis and electrolyte imbalance and other serious diseases;
  • Those who cannot stop antiplatelet drugs or anticoagulant drugs;
  • Those who have not completed full colonoscopy;
  • Pregnant women.

结局指标

主要结局

The accuracy of expert with or without AI

时间窗: June 2023

Concordance rate between expert experience and postoperative pathology

The accuracy of non-expert with or without AI

时间窗: June 2023

Concordance rate between non-expert experience and postoperative pathology

The accuracy of AI

时间窗: June 2023

Concordance rate between biopsy and postoperative pathology

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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