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Completed

NCT Number: NCT02688751

Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3

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.

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Key information

Conditions

Endoleak Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Liverpool Hospital

Liverpool, Merseyside, L7 8XP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 or over
  • Able to give informed consent
  • Undergone an EVAR of infra-renal abdominal aortic aneurysm
  • Planned for CTA of EVAR

Exclusion criteria

  • Unable to receive CTA Contrast Allergy, Insufficient renal function for standard outpatient contrast study (eGFR <45) Overactive thyroid gland
  • 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
  • Previous embolization of artery in region of EVAR (affects imaging quality)
  • BMI >30 (affects imaging quality)

Treatment and study plan

time-resolved CT Angiography

Radiation

A multi-phase contrast CT

Contrast Enhanced Ultrasound

Procedure

A ultrasound scan with micro bubble contrast injection

Other names: CEUS

Primary outcomes

  1. Ability to detect type I/III endoleak on CEUS as defined by presence/absence on tCTA

    Time frame: Immediate

    Will be presented as a Sensitivity & specificity

Secondary outcomes

  1. Ability to detect type II endoleak on CEUS as defined by presence/absence on tCTA

    Time frame: Immediate

    Will be presented as a Sensitivity & specificity

  2. Ability to predict secondary intervention on CEUS as defined by patients proceeding to secondary intervention

    Time frame: Immediate

    Will be presented as a Sensitivity & specificity

  3. Confirm / refute association between temporal delay measured on CEUS and endoleak type as defined by tCTA, using the framework of general linear regression.

    Time frame: Immediate

    Temporal delay is the time difference between contrast arriving in the stent graft and contrast arriving in the endoleak on CEUS

  4. 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

  5. Ability to predict secondary intervention of CDU, CEUS and tCTAas defined by patients proceeding to secondary intervention

    Time frame: 6 months

    Will be presented as a Sensitivity & specificity

  6. Time taken for CDU, CEUS & tCTA scans to be performed as measured by observer.

    Time frame: Immediate

    Used to calculate total resource utilisation by individual scan types.

Sponsors and collaborators

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust

Other Gov

Registry information

Official study title

Contrast Enhanced Ultrasound Endoleak Detection Compared To Time-Resolved Computer Tomography Angiography in High Risk Endovascular Aneurysm Repair (EVAR) Surveillance Patients.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2016
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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