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OpenTrials
Completed

NCT Number: NCT04880421

Diagnostic Performance of Arterial Time for CT Assessment of Parietal Enhancement Defect for the Diagnosis of Ischemia in Mechanical Small Bowel Occlusions: a Comparative Study With Portal Time

Intestinal obstruction is a frequent cause of emergency room visits and represents about 4-7% of the causes of acute abdominal pain syndrome and up to 30% in adults over 60 years old.

Although 65 to 80% of patients are treated medically, small bowel obstruction remains a serious pathology, with a high mortality rate that can reach 25% in case of small bowel ischemia. It is necessary to systematically perform a CT scan in the initial workup of small bowel obstructions to confirm the diagnosis, identify the mechanism and detect signs of ischemia that would require emergency surgery.

The best sign for the diagnosis of ischemia is the defect or asymmetry of parietal enhancement of the dilated small bowel. In the literature, this sign is described almost exclusively at portal time. In case of suspicion of mesenteric ischemia (another serious pathology affecting the small bowel), it is recommended to perform an examination with three acquisitions (without injection, arterial time, and portal time).

The department's experience has shown that arterial time is sometimes more sensitive than portal time for visualizing a parietal enhancement defect of the small bowel in mechanical occlusions.

Very few studies have investigated the diagnostic performance of parietal enhancement asymmetry on arterial time in mechanical occlusions of the small bowel.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient whose age is ≥ 18 years
  • Patient with a diagnosis of mechanical small bowel obstruction on CT performed between April 2014 and December 2019
  • Patient who had a CT scan with at least 3 phases: injection-free, arterial time, portal time
  • French-speaking patient

Exclusion criteria

  • Patient who did not have surgery within the first 24 hours
  • Patient with a history of abdomino-pelvic surgery in the month preceding the scan
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient who objects to the use of his or her data for this research

Treatment and study plan

Primary outcomes

  1. Diagnostic performance of arterial versus portal phase in CT for the evaluation of parietal enhancement defect

    Time frame: Year 1

    This ouctome corresponds to the evaluation of the sensitivity, specificity, positive predictive value and negative predictive value of the acquisition for parietal enhancement defect as a sign of ischemia.

Secondary outcomes

  1. Inter-observer reproducibility of parietal enhancement defect analysis at arterial time

    Time frame: Year 1

    This outcome corresponds to the evaluation of the Kappa coefficient of inter-observer reproducibility.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: PORTOGRELE

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
May 10, 2021
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.