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 (PORTOGRELE)

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients, over 18 years of age, with a diagnosis of mechanical small bowel obstruction on CT and having had a CT scan with at least 3 phases: injection-free, arterial time, portal time, were managed at GHPSJ between April 2014 and December 2019

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Year 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2021

Primary Completion (Actual)

June 27, 2021

Study Completion (Actual)

April 26, 2023

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PORTOGRELE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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