Clinical trial NCT02688751: Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3
Official title: Contrast Enhanced Ultrasound Endoleak Detection Compared To Time-Resolved Computer Tomography Angiography in High Risk Endovascular Aneurysm Repair (EVAR) Surveillance Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoleak
Abdominal Aortic Aneurysm
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2016-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients identified as being at increased risk of Type I/III endoleak following EVAR who require CTA \& CEUS to confirm/refute this diagnosis.

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.

Eligibility criteria: 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

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)

Primary outcomes:
measure: Ability to detect type I/III endoleak on CEUS as defined by presence/absence on tCTA
timeFrame: Immediate
Secondary outcomes:
measure: Ability to detect type II endoleak on CEUS as defined by presence/absence on tCTA
timeFrame: Immediate
measure: Ability to predict secondary intervention on CEUS as defined by patients proceeding to secondary intervention
timeFrame: Immediate
measure: Confirm / refute association between temporal delay measured on CEUS and endoleak type as defined by tCTA, using the framework of general linear regression.
timeFrame: Immediate
measure: Establish association between "CEUS contrast in endoleak" to "tCTA contrast in endoleak" by general linear regression analysis of timings recorded during CEUS & tCTA.
timeFrame: Immediate
measure: Ability to predict secondary intervention of CDU, CEUS and tCTAas defined by patients proceeding to secondary intervention
timeFrame: 6 months
measure: Time taken for CDU, CEUS & tCTA scans to be performed as measured by observer.
timeFrame: Immediate
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Hospital
state: Merseyside
Study officials:
affiliation: Liverpool University Hospitals NHS Foundation Trust
name: Srinivasa R Vallabhaneni, MD
role: STUDY_CHAIR
References:
citation: Roy IN, Chan TY, Czanner G, Wallace S, Vallabhaneni SR. Prospective, single UK centre, comparative study of the predictive values of contrast-enhanced ultrasound compared to time-resolved CT angiography in the detection and characterisation of endoleaks in high-risk patients undergoing endovascular aneurysm repair surveillance: a protocol. BMJ Open. 2018 Apr 3;8(4):e020835. doi: 10.1136/bmjopen-2017-020835.