Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3

L

Liverpool University Hospitals NHS Foundation Trust

Status

Completed

Conditions

Endoleak
Abdominal Aortic Aneurysm

Treatments

Radiation: time-resolved CT Angiography
Procedure: Contrast Enhanced Ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT02688751
15/NW/0908 (Other Identifier)
5083

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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