Diagnosing Acute Onset Insufficient Intestinal Blood Flow... | NCT04561323

Studies
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

NCT04561323

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Mar 10, 2021Actual

Enrollment

44Estimated

Phase

Not provided

Conditions

Bowel Ischemia
Acute Bowel Ischemia / Infarction

Interventions

Dual-energy CT

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Brief Title

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

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Apr 1, 2022Estimated

Completion Date

Apr 1, 2022Estimated

First Submitted Date

Sep 17, 2020

First Submission Date that Met QC Criteria

Sep 22, 2020

First Posted Date

Sep 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2021

Last Update Posted Date

Mar 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dual-energy CT	Diagnostic 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Intraoperative ICG fluorescence angiogram perfusion assessment and its correlation to DECT image evaluation.		10 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Referred on the suspicion of acute bowel ischemia

Exclusion Criteria:

Patient not scanned with DECT
Patient does not undergo abdominal surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Study population consists of admitted patients at Rigshospitalet, Denmark.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jack J Xu, MD	Contact	+4525122159		jack.junchi.xu@regionh.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Diagnostic Radiology, Rigshospitalet	Recruiting	Copenhagen		2100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis