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Abdominal Aortic AneurysmDeepLearnNCT04503226

Deep Learning Applied to Plain Abdominal Radiographic Surveillance After Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA)

An observational study of Abdominal Aortic Aneurysm, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Deep learning applied to plain abdominal radiographic surveillance after Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA). Read more about this study

Who is it for?
Any age
Conditions the study is for
Abdominal Aortic Aneurysm
How many people
800 participants
Where
1 siteUnited Kingdom
Study dates
1 Oct 2019to 31 Dec 2020
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients (approximately n = 800) who have undergone EVAR at the Royal Liverpool University Hospital between 2005 and 2013.

Who may be able to join

  • Patients who have undergone EVAR at the Royal Liverpool University Hospital between 2005 and 2013.
  • Patients who were treated for standard infra-renal AAAs.
  • Patients who are on our post-operative surveillance programme and have had 5 plain abdominal radiographs to date.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University of Liverpool

    Liverpool, Merseyside, L7 8TX

Other trials in United Kingdom

About this study

Deep learning applied to plain abdominal radiographic surveillance after Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA).

Read the detailed description

Abdominal aortic aneurysm (AAA) is a condition in which the abdominal aorta, a large artery, dilates gradually, secondary to a degenerative process within its wall. This can lead to rupture of the weakened wall with subsequent exsanguination into the abdomen. This scenario is usually fatal. The diameter of the aneurysm positively correlates with the risk of rupture. Aneurysm size is therefore the primary determinant when considering whether or not to electively repair AAAs.

Endovascular aneurysm repair (EVAR) has become the standard treatment for AAAs in the vast majority of patients. It is a minimally invasive technique that aims to exclude the aneurysm from the circulation by placement of a synthetic "stent-graft" within the aortic lumen. Metallic barbs as well as radial force maintain stent-graft position in non-aneurysmal aorta above the aneurysm as well as in the iliac arteries below the aneurysm.

Level 1 evidence has consistently demonstrated improved perioperative survival with EVAR as compared to traditional open surgery. However, there are concerns regarding the long-term durability of EVAR stent-grafts, with 1 in 5 patients requiring further surgery to the aneurysm in the 5 years after the operation. This is often due to failure of the position and integrity of the stent-graft. Therefore, standard international practice is to keep patients are life-long surveillance after EVAR. This is usually in the form of plain radiographs in combination with either computerised tomography (CT) or duplex ultrasound scans, all performed on an annual basis.

Stent-grafts are visible on plain radiographs of the abdomen and by comparing series of images taken over time, it is possible to diagnose a myriad of stent-graft problems including migration, disintegration and distortion. But these changes can be subtle on plain radiographs and difficult to spot, even to the most trained human eye. As a result, patients undergo more detailed scans that unfortunately carry a risk of nephrotoxicity and radiation-induced malignancy.

The aim of our research is to improve the diagnostic potential of plain radiographs by applying modern deep learning computer algorithms for interpretation.

Artificial intelligence (AI) in the form of deep learning has shown great success in recent years on numerous challenging problems. The success of deep learning is largely underpinned by advances in powerful graphics processing units (GPUs). GPUs enable us to speed up training algorithms by orders of magnitude, bringing run-times of weeks down to days.

Our study will explore the use of artificial intelligence in interpreting series of anonymised plain radiographs to identify features of a failing stent-graft.

A deep-learning algorithm will be applied to post-EVAR plain radiographs that have already been performed at our institution in England over the last 10 years. We will then compare the effectiveness of the machine in identifying stent-graft related problems to the known outcomes identified by human interpretation previously.

This project will rely on recent advances in deep learning techniques. It is expected that deep learning will bring good performance for EVAR surveillance in line with its successful application in domains such as the recognition of digits, Chinese characters, and traffic signs where computers have produced better accuracy than humans.

Keywords
Endovascular Aneurysm Repair, Surveillance, Device migration, Device disintegration
Medical subject headings
Aortic Aneurysm, Abdominal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic Accuracy

    The diagnostic accuracy of deep learning based algorithm compared to trained human interpretation in the detection of stent graft migration, disintegration and distortion on plain x-rays after EVAR.

    Measured: 1-10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2020
  2. Study start1 Oct 2019
  3. Primary completion15 Oct 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

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
Case only
Time perspective
Retrospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04503226
Sponsor's protocol ID
5851
Acronym
DeepLearn
Status last verified
Aug 2019
First submitted
4 Aug 2020
Last updated
7 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Aug 2020. 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?

Results are not available in the source record.

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?

Diagnostic Accuracy (time frame: 1-10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Aug 2020.

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