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
Dual-energy CT in the Diagnosis of All-Cause Acute Bowel Ischemia
1 other identifier
observational
44
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedMarch 10, 2021
March 1, 2021
1.4 years
September 17, 2020
March 8, 2021
Conditions
Keywords
Outcome Measures
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.
10 minutes
Secondary Outcomes (1)
Intraoperative ICG fluorescence angiogram perfusion assessment and its correlation to DECT image evaluation.
10 minutes
Interventions
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.
Eligibility Criteria
Study population consists of admitted patients at Rigshospitalet, Denmark.
You may qualify if:
- Referred on the suspicion of acute bowel ischemia
You may not qualify if:
- Patient not scanned with DECT
- Patient does not undergo abdominal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Diagnostic Radiology, Rigshospitalet
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 17, 2020
First Posted
September 23, 2020
Study Start
November 1, 2020
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
March 10, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share