Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3

NCT02688751 | Completed

• 2 other identifiers: 508315/NW/0908
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoleak; Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  Immediate

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

  Immediate

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

  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

  6 months

Interventions

time-resolved CT Angiography RADIATION

A multi-phase contrast CT

Contrast Enhanced Ultrasound PROCEDURE

A ultrasound scan with micro bubble contrast injection

Also known as: CEUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Liverpool Hospital

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29615450 DERIVED

MeSH Terms

Conditions

Endoleak; Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

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

Study Officials

• Srinivasa R Vallabhaneni, MD

  Liverpool University Hospitals NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: February 23, 2016
• Study Start: January 20, 2016
• Primary Completion: March 20, 2018
• Study Completion: March 20, 2018
• Last Updated: June 9, 2022

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)