NCT04561323

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

September 17, 2020

Last Update Submit

March 8, 2021

Conditions

Keywords

Dual-energy CT

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

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Infarction

Condition Hierarchy (Ancestors)

IschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

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

Locations