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临床试验/NCT04503226
NCT04503226Unknown不适用

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

Liverpool University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
800
试验地点
1
主要终点
Diagnostic Accuracy

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who have undergone EVAR at the Royal Liverpool University Hospital between 2005 and
  • 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.

排除标准

  • 未提供

结局指标

主要结局

Diagnostic Accuracy

时间窗: 1-10 years

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.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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