ClinicalTrials.gg
Status unknownNCT04561323Updated Mar 10, 2021

Diagnosing Acute Onset Insufficient Intestinal Blood Flow (Bowel Ischemia) With a Novel CT Technique Called Dual-energy CT (DECT). This Observational Study Seeks to Evaluate Whether DECT Can Improve the Diagnosis of Bowel Ischemia and How the DECT Findings Correlate With Intraoperative Findings

An observational study in Bowel Ischemia and Acute Bowel Ischemia / Infarction, sponsored by Rigshospitalet, Denmark. Status unknown at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2021-03-10.

Sponsored by Rigshospitalet, Denmark · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
44
Sex
All
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Study summary

The aim of this study is to evaluate the performance of dual-energy CT (DECT) in the diagnosis of acute bowel ischemia (ABI). ABI is a condition characterised by inadequate blood supply to portions of the intestine. ABI is a relatively rare condition, but is associated with a high mortality rate.

DECT is an emerging field within radiology. Few reports have reported an increased conspicuity for ABI using DECT compared with conventional CT, which is the current preoperative golden standard.

The investigators hypothesize that DECT increases conspicuity of ABI compared with conventional CT and that DECT image findings correlate with the intraoperative findings.

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Conditions studied

  • Bowel Ischemia
  • Acute Bowel Ischemia / Infarction

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Keywords

  • Dual-energy CT
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In context

Infarction

71 studies on the registry are indexed under Infarction; 15 are open to participants now.

This study's planned enrollment of 44 is below the median of 119 across 23 observational studies indexed under Infarction.

Browse Infarction studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study population consists of admitted patients at Rigshospitalet, Denmark.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Referred on the suspicion of acute bowel ischemia

Exclusion criteria

Exclusion Criteria:

  • Patient not scanned with DECT
  • Patient does not undergo abdominal surgery
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
44 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testDual-energy CT

    Patients suspected of acute bowel ischemia will be scanned in the dual-energy CT scanner. The abdominal imaging protocols are predetermined by the Department of Diagnostic Radiology, Righospitalet, Denmark.

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What researchers measure

Primary outcomes

  1. Adding DECT information increases assessor confidence without lowering the specificity compared with standard CT in the diagnosis and/or exclusion of ABI.

    Time frame: 10 minutes

Secondary outcomes

  1. Intraoperative ICG fluorescence angiogram perfusion assessment and its correlation to DECT image evaluation.

    Time frame: 10 minutes

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Study locations

1 of 1 sites recruiting
  • Department of Diagnostic Radiology, Rigshospitalet
    Copenhagen, 2100, Denmark
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2020 (actual). Primary completion is estimated for Apr 2022, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2020
First posted
Sep 23, 2020
StartActual
Nov 1, 2020
Primary completionEst.
Apr 1, 2022
CompletionEst.
Apr 1, 2022
Last update
Mar 10, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04561323
Responsible party
Jack Xu (Principal Investigator, Rigshospitalet, Denmark) — Principal investigator
First posted
Sep 23, 2020
Start date
Nov 1, 2020
Primary completion
Apr 1, 2022 (estimated)
Completion
Apr 1, 2022 (estimated)
Last update
Mar 10, 2021

Study contacts

Jack J Xu, MD
Contact
jack.junchi.xu@regionh.dk
+4525122159

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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