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| ID | Type | Description | Link |
|---|---|---|---|
| 15/NW/0908 | Other Identifier | NHS REC |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| time-resolved CT Angiography | Radiation | A multi-phase contrast CT | ||
| Contrast Enhanced Ultrasound | Procedure | A ultrasound scan with micro bubble contrast injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability to detect type I/III endoleak on CEUS as defined by presence/absence on tCTA | Will be presented as a Sensitivity & specificity | Immediate |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to detect type II endoleak on CEUS as defined by presence/absence on tCTA | Will be presented as a Sensitivity & specificity | Immediate |
| Ability to predict secondary intervention on CEUS as defined by patients proceeding to secondary intervention |
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Inclusion Criteria:
Exclusion Criteria:
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Patients identified as being at increased risk of Type I/III endoleak following EVAR who require CTA & CEUS to confirm/refute this diagnosis.
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| Name | Affiliation | Role |
|---|---|---|
| Srinivasa R Vallabhaneni, MD | Liverpool University Hospitals NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Liverpool Hospital | Liverpool | Merseyside | L7 8XP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29615450 | Derived | 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. |
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| ID | Term |
|---|---|
| D057867 | Endoleak |
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019106 | Postoperative Hemorrhage |
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Will be presented as a Sensitivity & specificity |
| Immediate |
| Confirm / refute association between temporal delay measured on CEUS and endoleak type as defined by tCTA, using the framework of general linear regression. | Temporal delay is the time difference between contrast arriving in the stent graft and contrast arriving in the endoleak on CEUS | Immediate |
| Establish association between "CEUS contrast in endoleak" to "tCTA contrast in endoleak" by general linear regression analysis of timings recorded during CEUS & tCTA. | Immediate |
| Ability to predict secondary intervention of CDU, CEUS and tCTAas defined by patients proceeding to secondary intervention | Will be presented as a Sensitivity & specificity | 6 months |
| Time taken for CDU, CEUS & tCTA scans to be performed as measured by observer. | Used to calculate total resource utilisation by individual scan types. | Immediate |
| D006470 |
| Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D001014 | Aortic Aneurysm |
| D001018 | Aortic Diseases |