To determine FDG uptake following uncomplicated EVAR using the Nellix endoprosthesis. Does uncomplicated EVAR using the Nellix endoprosthesis result in increased FDG uptake and false positive PET imaging? .
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
FDG, Standard Uptake Values (SUV).
Secondary outcome
inflammation assessed by known inflammatory markers (e.g. CRP and leukocyte
count).
Background summary
Abdominal aortic aneurysm (AAA) is a prevalent disorder affecting 4.3 to 8.8%
of men over the age of 60.1 Since the introduction of endovascular aneurysm
repair (EVAR) in the early 1990*s, EVAR is performed in the majority of
patients to prevent rupture.
One of the most devastating complications following EVAR is infection of the
used endograft. Because of the high mortality associated with endograft
infection, patients with a possible graft infection are treated with life-long
broadspectrum antibiotics. Unfortunately, the diagnosis is difficult and PET
imaging is often used as a tool to support diagnosis and to initiate life long
antibiotic treatment or even secondary surgery.
Following endograft placement, the aortic wall shows extensive inflammation and
increased metabolic activity. This is probably related to the insertion of the
prosthetic graft material itself and the mechanical manipulation and
deformation (strain) following endograft placement. The increased metabolic
activity in the aortic wall following EVAR might result in positive PET
findings. This could limit the use of PET imaging to identify endograft
infection and questions the use of life-long broadspectrum antibiotic treatment
in patients with a PET positive finding following EVAR.
The Nellix endoprosthesis is a relatively new device used for EVAR. The
difference with traditional endografts is that the entire aneurysm is filled by
two polymer-filled endobags, with two balloon expandable stents preserving flow
to the lower extremity. With this new device endoleaks, aneurismal flow outside
the stents, are less likely to occur and also migration is rare. In present
literature there is no data on the degree of physiologic inflammation following
implantation of a Nellix device and the value of postoperative FDG-PET imaging
to detect infection is not known. This makes the diagnosis of infection
following Nellix implantation extremely difficult.
Study objective
To determine FDG uptake following uncomplicated EVAR using the Nellix
endoprosthesis. Does uncomplicated EVAR using the Nellix endoprosthesis result
in increased FDG uptake and false positive PET imaging? .
Study design
Observational case series (pilot).
Study burden and risks
Regular preoperative and follow-up imaging for EVAR planning and follow-up
using the Nellix endoprosthesis consists of Computed Tomography Angiography
preoperative and at six weeks, six months and one year after EVAR. In this
study the preoperative and first follow-up CTA (6 weeks after EVAR) will be
replaced by a PET/CTA. Regular blood samples are collected prior to CTA to
determine kidney function. For patients included in the study, additionally
several inflammation markers will be determined. (leukocyte count and CRP).
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
•scheduled endovascular aneurysm repair using the Nellix endoprosthesis.
•Informed consent
Exclusion criteria
Diabetes Mellitus type 1 en 2.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL50251.091.14 |