Clinical Trial: Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Contrast Enhanced Ultrasound Endoleak Detection Compared To Time-Resolved Computer Tomography Angiography in High Risk Endovascular Aneurysm Repair (EVAR) Surveillance Pat

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 Summary:

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.


Sponsor: Royal Liverpool and Broadgreen University Hospitals NHS Trust

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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
  • 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 [ Time Frame: 6 months ]
    Will be presented as a Sensitivity & specificity
  • 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.


Original Secondary Outcome: Same as current

Information By: Royal Liverpool and Broadgreen University Hospitals NHS Trust

Dates:
Date Received: December 16, 2015
Date Started: February 2016
Date Completion: April 2018
Last Updated: October 7, 2016
Last Verified: September 2016