跳至主要内容
临床试验/NCT05566158
NCT05566158进行中(未招募)不适用

Development and Validation of a CT-based Diagnostic Models Using Artificial Intelligence for Detection of Small Bowel Obstruction

Fondation Hôpital Saint-Joseph2 个研究点 分布在 1 个国家目标入组 8,000 人开始时间: 2022年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
8,000
试验地点
2
主要终点
Automated detection of digestive occlusions

研究概览

简要总结

Small bowel obstruction (SBO) is a common non-traumatic surgical emergency. All guidelines recommend computed tomography (CT) as the first-line imaging test for patients with suspected SBO. The objectives of CT are multiple: (i) to confirm or refute the diagnosis of GI obstruction, defined as distension of the digestive tracts greater than 25 mm, and, when SBO is present, (ii) to confirm the mechanism (mechanical vs. functional), (iii) to localize the site of obstruction, i.e., the transition zone (TZ), (iv) to identify the cause, and (v) to look for complications such as strangulation or perforation, influencing management.

Given the exponential increase in the number of scans being performed, especially in the setting of emergency management, methods to assist the radiologist would be useful to:

  1. Sort the scans performed, allowing prioritization of the analysis of scans with a higher probability of pathology (occlusion in our case)
  2. Help the radiologist to diagnose occlusion and its type (functional or mechanical), and to identify signs of severity.
  3. To help the emergency physician and the digestive surgeon to make a decision on the management of the disease (surgical or medical).

Machine learning has developed rapidly over the last decades, first thanks to the increase in data storage capacities, then thanks to the arrival of parallel processing hardware based on graphic processing units, in the context of radiological diagnostic assistance. Consequently, the number of studies on deep neural networks in medical imaging is increasing rapidly. However, few teams focus on SBO. The only published classification models have been produced for standard abdominal radiographs. No studies have used CT or 3D models, apart from our preliminary study on ZTs, despite the recognized advantages of CT for the diagnosis of SBO and the likely contribution of 3D models, which may be comparable to that of multiplanar reconstruction for the analysis of images in multiple planes of space.

研究设计

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

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

  • Patient whose age ≥ 18 years
  • Patient who has had a CT scan with at least one abdominal-pelvic acquisition performed within the Saint Joseph Hospital Group
  • Report containing the terms "occlusion" or "occlusive", "vomiting" or "ileus"
  • French-speaking patient

排除标准

  • Imaging not usable
  • Absence of abdomino-pelvic volume on CT acquisitions
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his data for this research

结局指标

主要结局

Automated detection of digestive occlusions

时间窗: Year 1

This outcome corresponds to the ability of the model to identify the presence or absence of occlusion: sensitivity, specificity and predictive values.

次要结局

  • Analysis via radiomics of junction zones(Year 1)
  • Automatic differentiation of functional vs. mechanical occlusions(Year 1)
  • Algorithm for surgical indication(Year 1)
  • Automated detection of junction areas(Year 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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