Bowel IschemiaNCT04561323
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 of Bowel Ischemia and Acute Bowel Ischemia / Infarction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bowel Ischemia, Acute Bowel Ischemia / Infarction
- What is being tested?
- Dual-energy CT
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2020to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population consists of admitted patients at Rigshospitalet, Denmark.
Who may be able to join
- Referred on the suspicion of acute bowel ischemia
Who cannot join
- Patient not scanned with DECT
- Patient does not undergo abdominal surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Diagnostic Radiology, Rigshospitalet
Copenhagen, 2100
Jack J Xu, MD, 25122159, jackxu1990@hotmail.com
About this study
Official title: Dual-energy CT in the Diagnosis of All-Cause Acute Bowel Ischemia
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.
- Conditions
- Bowel Ischemia, Acute Bowel Ischemia / Infarction
- Being tested
- Dual-energy CT
- Keywords
- Dual-energy CT
- Medical subject headings
- Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-energy CTDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adding DECT information increases assessor confidence without lowering the specificity compared with standard CT in the diagnosis and/or exclusion of ABI.
Measured: 10 minutes
Secondary outcomes (1)
Intraoperative ICG fluorescence angiogram perfusion assessment and its correlation to DECT image evaluation.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Nov 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel IschemiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jack Xu, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561323
- Sponsor's protocol ID
- H-20029655
- Status last verified
- Mar 2021
- First submitted
- 17 Sep 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-energy CT in the Diagnosis of All-Cause Acute Bowel Ischemia
- ClinicalTrials.gov ID
- NCT04561323
- Acronym / sponsor ID
- H-20029655
- Conditions
- Bowel Ischemia, Acute Bowel Ischemia / Infarction
- Keywords
- Dual-energy CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population consists of admitted patients at Rigshospitalet, Denmark.
Key inclusion criteria (1 listed)
- Referred on the suspicion of acute bowel ischemia
Key exclusion criteria (2 listed)
- Patient not scanned with DECT
- Patient does not undergo abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-energy CTPatients 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. | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
Intraoperative ICG fluorescence angiogram perfusion assessment and its correlation to DECT image evaluation.
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Ischemia and Acute Bowel Ischemia / Infarction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jack J Xu, MD (+4525122159, jack.junchi.xu@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.