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

Bowel Ischemia Clinical Trial

Official title:

Dual-energy CT in the Diagnosis of All-Cause Acute Bowel Ischemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04561323
• Other study ID #: H-20029655
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Bowel Ischemia / Infarction
• Bowel Ischemia
• Infarction
• Ischemia
• Mesenteric Ischemia

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