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Clinical Trials/NCT05566158
NCT05566158Active, not recruitingNot Applicable

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

Fondation Hôpital Saint-Joseph2 sites in 1 country8,000 target enrollmentStarted: August 9, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
8,000
Locations
2
Primary Endpoint
Automated detection of digestive occlusions

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Automated detection of digestive occlusions

Time Frame: Year 1

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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