EndoleakNCT02688751
Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3
An observational study of Endoleak and Abdominal Aortic Aneurysm, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoleak, Abdominal Aortic Aneurysm
- What is being tested?
- time-resolved CT Angiography and Contrast Enhanced Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jan 2016to 20 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged 18 or over
- Able to give informed consent
- Undergone an EVAR of infra-renal abdominal aortic aneurysm
- Planned for CTA of EVAR
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool Hospital
Liverpool, Merseyside, L7 8XP
About this study
Official title: 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.
Read the 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.
- Conditions
- Endoleak, Abdominal Aortic Aneurysm
- Being tested
- time-resolved CT Angiography, Contrast Enhanced Ultrasound
- Medical subject headings
- Endoleak, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time-resolved CT AngiographyRadiation
A multi-phase contrast CT
Contrast Enhanced UltrasoundProcedure or surgery
Also called CEUS
A ultrasound scan with micro bubble contrast injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to detect type I/III endoleak on CEUS as defined by presence/absence on tCTA
Will be presented as a Sensitivity \& specificity
Measured: Immediate
Secondary outcomes (6)
Ability to detect type II endoleak on CEUS as defined by presence/absence on tCTA
Will be presented as a Sensitivity \& specificity
Measured: Immediate
Ability to predict secondary intervention on CEUS as defined by patients proceeding to secondary intervention
Will be presented as a Sensitivity \& specificity
Measured: 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
Measured: Immediate
Establish association between "CEUS contrast in endoleak" to "tCTA contrast in endoleak" by general linear regression analysis of timings recorded during CEUS & tCTA.
Measured: 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
Measured: 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.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start20 Jan 2016
- Primary completion20 Mar 2018
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndoleakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Srinivasa R Vallabhaneni, MD, Study chair, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688751
- Sponsor's protocol ID
- 5083
- Other IDs
- 15/NW/0908
- Status last verified
- Sep 2016
- First submitted
- 16 Dec 2015
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29615450
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Ultrasound Endoleak Detection Compared To Time-Resolved Computer Tomography Angiography in High Risk Endovascular Aneurysm Repair (EVAR) Surveillance Patients.
- ClinicalTrials.gov ID
- NCT02688751
- Acronym / sponsor ID
- 5083
- Conditions
- Endoleak, Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Aged 18 or over
- Able to give informed consent
- Undergone an EVAR of infra-renal abdominal aortic aneurysm
- Planned for CTA of EVAR
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| time-resolved CT AngiographyA multi-phase contrast CT | Radiation | – |
| Contrast Enhanced UltrasoundAlso: CEUSA ultrasound scan with micro bubble contrast injection | Procedure or surgery | – |
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
6 secondary outcomes
Ability to detect type II endoleak on CEUS as defined by presence/absence on tCTA
Time frame: Immediate
Ability to predict secondary intervention on CEUS as defined by patients proceeding to secondary intervention
Time frame: Immediate
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
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
Time taken for CDU, CEUS & tCTA scans to be performed as measured by observer.
Time frame: Immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Derived from this study: PubMed 29615450Roy 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.
- Individual participant dataSharing planned: No
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Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms
Technical Sucess, Freedom From Type I and III Endoleaks at 12 Months
Not yet recruitingObservational study
Deep-learning Predictors of Abdominal Aortic Aneurysm Enlargement in Type II Endoleaks After Endovascular Aortic Repair: The RADAR Study
Type II Endoleak, Abdominal Aortic Aneurysm Enlargement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinivasa R Vallabhaneni, MD study chair
Liverpool University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoleak and Abdominal Aortic Aneurysm, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to detect type I/III endoleak on CEUS as defined by presence/absence on tCTA (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02688751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.