PET-CT After Nellix Implantation
Palabras clave
Abstracto
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
Intervención / tratamiento
Device: Treated group
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Treated group Patient group treated with Nellix Endoprosthesis. | Device: Treated group Implantation of Nellix |
Criterio de elegibilidad
Sexos elegibles para estudiar | All |
Método de muestreo | Non-Probability Sample |
Acepta voluntarios saludables | si |
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]