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临床试验/NCT05858827
NCT05858827已完成不适用

To Evaluate the Capability of an Endoscopic Ultrasonography Automatic Image Reporting System

Renmin Hospital of Wuhan University1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2023年5月10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
114
试验地点
1
主要终点
completeness of capturing standard stations

研究概览

简要总结

In this study, the EUS intelligent picture reporting system can automatically generate reports after reading videos of EUS examinations. This function can standardize the quality of endoscopic ultrasound image reporting and reduce the work burden of ultrasound endoscopists.

详细描述

A well-written report is the most important way of communication between clinicians, referring doctors and patients. Reports play a key role for quality improvement in digestive endoscopy, too. Unlike digestive endoscopy, the quality of reporting in endoscopic ultrasound (EUS) has not been thoroughly evaluated and a reference standard is lacking. According to the guidance statements regarding standard EUS reporting elements developed and reviewed at the Forum for Canadian Endoscopic Ultrasound 2019 Annual Meeting, appropriate photo documentation of all relevant lesions and anatomical landmarks should be included in EUS reports and stored for future reference. Systematic photo documentation in EUS is an indicator of procedure quality according to the ASGE. Systematic photo documentation can facilitate surveillance EUS evaluations. According to an international online survey, most endosonographers used a structured tree in the report describing either normal and abnormal findings (81%) or only abnormal findings (7%). Therefore, it is necessary to develop a standardized endoscopic ultrasound image report system.

The past decades have witnessed the remarkable progress of artificial intelligence (AI) in the medical field. Deep learning, a subset of AI, has shown great potential in elaborating image analysis. In the field of digestive endoscopy, deep learning has been widely studied, including identifying focal lesions, differentiating malignant and non-malignant lesions, and so on. However, rare study works on automatic photo documentation during endoscopic ultrasound.

Our previous work has successfully developed a deep learning EUS navigation system that can identify the standard stations of the pancreas and CBD in real time. In the present study, we further constructed an EUS automatic image reporting system (EUS-AIRS). The EUS-AIRS can automatically capture images of standard stations, lesions, and biopsy procedures, and label Types of lesions, thereby generating an image report with high completeness and quality during endoscopic ultrasonography.

We tested the performance of the EUS-AIRS by testing its performance on retrospective internal and external data, and we anticipate determining the utility of the EUS-AIRS in clinical practice by testing its performance in consecutive prospective patients.

研究设计

研究类型
Observational
观察模型
Other
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

  • patients aged 18 years or older;
  • patients with indications for endoscopic ultrasonography of the biliary pancreatic system and undergoing sedated EUS procedures;
  • ability to read, understand, and sign informed consent;

排除标准

  • patients with absolute contraindications to EUS examination;
  • history of previous gastric surgery;
  • severe medical illness;
  • previous medical history of allergic reaction to anesthetics;
  • stricture or obstruction of the esophagus;
  • anatomical abnormalities of the upper gastrointestinal tract due to advanced neoplasia.

结局指标

主要结局

completeness of capturing standard stations

时间窗: 2 months

The number of standard stations correctly captured by EUS-AIRS is divided by the number of all standard stations in the endoscopic ultrasound procedures

次要结局

  • completeness of capturing detected lesions(2 months)
  • accuracy of capturing standard stations(2 months)
  • completeness of capturing biopsy procedures(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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