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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04561323
Other study ID # H-20029655
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date April 1, 2022

Study information

Verified date March 2021
Source Rigshospitalet, Denmark
Contact Jack J Xu, MD
Phone +4525122159
Email jack.junchi.xu@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date April 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Referred on the suspicion of acute bowel ischemia Exclusion Criteria: - Patient not scanned with DECT - Patient does not undergo abdominal surgery

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Dual-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.

Locations

Country Name City State
Denmark Department of Diagnostic Radiology, Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adding DECT information increases assessor confidence without lowering the specificity compared with standard CT in the diagnosis and/or exclusion of ABI. 10 minutes
Secondary Intraoperative ICG fluorescence angiogram perfusion assessment and its correlation to DECT image evaluation. 10 minutes
See also
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