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PET-CT After Nellix Implantation

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EstadoTerminado
Patrocinadores
Rijnstate Hospital

Palabras clave

Abstracto

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?

Descripción

One of the most devastating complications following endovascular aneurysm repair (EVAR) is infection of the used endoprosthesis. Because of the high mortality of secondary surgery following infection, patients with a possible endoprosthesis infection are treated using broadspectrum antibiotics during months, years or even life-long. Unfortunately, the diagnosis of an endoprosthesis infection is difficult and based upon clinical suspicion and non-specific symptoms (e.g. fever and weigth loss) only. Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) is often used as a diagnostic tool to identify infection following EVAR. Like infection, sterile physiologic inflammation following EVAR is also associated with increased metabolism and FDG uptake. This could result in (false-)positive PET imaging resulting in diagnostic errors and antibiotic overuse.

The Nellix endoprosthesis is a relatively new device used for EVAR. 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. This pilot is designed to determine physiologic FDG uptake following uncomplicated EVAR using the Nellix endoprosthesis.

fechas

Verificado por última vez: 03/31/2017
Primero enviado: 01/11/2015
Inscripción estimada enviada: 01/21/2015
Publicado por primera vez: 01/27/2015
Última actualización enviada: 04/09/2017
Última actualización publicada: 04/10/2017
Fecha de inicio real del estudio: 12/31/2014
Fecha estimada de finalización primaria: 07/12/2016
Fecha estimada de finalización del estudio: 08/29/2016

Condición o enfermedad

Aortic Aneurysm
Endovascular Repair

Intervención / tratamiento

Device: Treated group

Fase

-

Grupos de brazos

BrazoIntervención / tratamiento
Treated group
Patient group treated with Nellix Endoprosthesis.
Device: Treated group
Implantation of Nellix

Criterio de elegibilidad

Sexos elegibles para estudiarAll
Método de muestreoNon-Probability Sample
Acepta voluntarios saludablessi
Criterios

Inclusion Criteria:

- Patients treated with Nellix endoprosthesis

Exclusion Criteria:

- Diabetes Mellitus (Type 1 and type 2)

- Current known inflammation or malignancy

Salir

Medidas de resultado primarias

1. Difference in physiological FDG uptake following Nellix EVAS implantation in patients without known infections or malignancies as measured by standard uptake values (SUV) [1 month]

Comparing pre- and post-implantation FDG uptake with ROI set at the aneurysm and stent. Measured SUV from FDG emission will be compared and subtracted and the difference will be reported (in MBq/kg).

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