An observational study in Endoleak and Abdominal Aortic Aneurysm, sponsored by Liverpool University Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-09.
Sponsored by Liverpool University Hospitals NHS Foundation Trust · Observational
A single site cross-sectional comparison of paired diagnostic imaging modalities.
This study will show the sensitivity and specificity of CEUS in detecting the various types of endoleaks, in comparison to tCTA, following EVAR. It will collect data to allow comparison of diagnostic accuracy across modalities including CDU, CEUS and tCTA. It will collect time taken to perform the various types of scan, to allow healthcare costs to be calculated for each imaging modality.
This study will show the sensitivity and specificity of CEUS in detecting the various types of endoleaks, in comparison to tCTA, following EVAR. It will collect data to allow comparison of diagnostic accuracy across modalities including CDU, CEUS and tCTA. It will collect time taken to perform the various types of scan, to allow healthcare costs to be calculated for each imaging modality.
Collected data will be analysed regarding two novel hypothesised methods of using CEUS information:
The first is recording temporal delay between contrast in graft and contrast in endoleak to define endoleak type. Potentially this could be used as a faster method of defining endoleak type in a surveillance programme.
The second is to identify/refute correlation between CEUS contrast to appear in endoleak vs tCTA contrast to appear in endoleak. If an association can be established, CEUS timings could potentially then be used to time 'standard' CTA phases to improve CTAs diagnostic accuracy.
31 studies on the registry are indexed under Endoleak; 7 are open to participants now.
This study's enrollment of 30 is below the median of 65 across 15 observational studies indexed under Endoleak.
Browse Endoleak studies →Liverpool University Hospitals NHS Foundation Trust is the lead sponsor of 61 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients identified as being at increased risk of Type I/III endoleak following EVAR who require CTA \& CEUS to confirm/refute this diagnosis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A multi-phase contrast CT
A ultrasound scan with micro bubble contrast injection
Also known as: CEUS
Ability to detect type I/III endoleak on CEUS as defined by presence/absence on tCTA
Will be presented as a Sensitivity \& specificity
Time frame: Immediate
Ability to detect type II endoleak on CEUS as defined by presence/absence on tCTA
Will be presented as a Sensitivity \& specificity
Time frame: Immediate
Ability to predict secondary intervention on CEUS as defined by patients proceeding to secondary intervention
Will be presented as a Sensitivity \& specificity
Time frame: Immediate
Confirm / refute association between temporal delay measured on CEUS and endoleak type as defined by tCTA, using the framework of general linear regression.
Temporal delay is the time difference between contrast arriving in the stent graft and contrast arriving in the endoleak on CEUS
Time frame: Immediate
Establish association between "CEUS contrast in endoleak" to "tCTA contrast in endoleak" by general linear regression analysis of timings recorded during CEUS & tCTA.
Time frame: Immediate
Ability to predict secondary intervention of CDU, CEUS and tCTAas defined by patients proceeding to secondary intervention
Will be presented as a Sensitivity \& specificity
Time frame: 6 months
Time taken for CDU, CEUS & tCTA scans to be performed as measured by observer.
Used to calculate total resource utilisation by individual scan types.
Time frame: Immediate
Plan to share: No
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Liverpool University Hospitals NHS Foundation Trust