Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm; Endoleak
• Intervention / Treatment: Radiation: time-resolved CT Angiography; Procedure: Contrast Enhanced Ultrasound

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L7 8XP
      • Royal Liverpool Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Liverpool University Hospitals NHS Foundation Trust
• Investigators: Study Chair: Srinivasa R Vallabhaneni, MD, Liverpool University Hospitals NHS Foundation Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2016
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): March 20, 2018

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Hemorrhage; Aortic Diseases; Postoperative Hemorrhage; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Endoleak
• Other Study ID Numbers: 5083; 15/NW/0908 (Other Identifier: NHS REC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No