Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3

Completed

• Conditions: Endoleak; Abdominal Aortic Aneurysm

• Registration Number: NCT02688751
• Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-12-16
• Study Start: 2016-01-20
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Status Verified: 2016-09
• Primary Completion: 2018-03-20
• Study Completion: 2018-03-20
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Aged 18 or over
2. Able to give informed consent
3. Undergone an EVAR of infra-renal abdominal aortic aneurysm
4. Planned for CTA of EVAR

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Exclusion Criteria

1. Unable to receive CTA Contrast Allergy, Insufficient renal function for standard outpatient contrast study (eGFR <45) Overactive thyroid gland
2. Unable to receive CEUS contrast Previous reaction to Sonovue (Ultrasound Contrast) Allergy to sulphur hexafluoride (used in electrical industry in circuit breakers, switch gears & electrical equipment) Recent acute coronary syndrome or unstable angina, typical angina at rest or frequent or repeated angina/chest pain - all within previous 7 days Recent coronary intervention
3. Previous embolization of artery in region of EVAR (affects imaging quality)
4. BMI >30 (affects imaging quality)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ability to detect type I/III endoleak on CEUS as defined by presence/absence on tCTA	Immediate	Will be presented as a Sensitivity \& specificity

Secondary Outcome Measures

Name	Time	Method
Ability to predict secondary intervention on CEUS as defined by patients proceeding to secondary intervention	Immediate	Will be presented as a Sensitivity \& specificity
Confirm / refute association between temporal delay measured on CEUS and endoleak type as defined by tCTA, using the framework of general linear regression.	Immediate	Temporal delay is the time difference between contrast arriving in the stent graft and contrast arriving in the endoleak on CEUS
Establish association between "CEUS contrast in endoleak" to "tCTA contrast in endoleak" by general linear regression analysis of timings recorded during CEUS & tCTA.	Immediate
Time taken for CDU, CEUS & tCTA scans to be performed as measured by observer.	Immediate	Used to calculate total resource utilisation by individual scan types.
Ability to predict secondary intervention of CDU, CEUS and tCTAas defined by patients proceeding to secondary intervention	6 months	Will be presented as a Sensitivity \& specificity
Ability to detect type II endoleak on CEUS as defined by presence/absence on tCTA	Immediate	Will be presented as a Sensitivity \& specificity

Trial Locations

Locations (1)

Royal Liverpool Hospital; 🇬🇧 Liverpool, Merseyside, United Kingdom