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A Retrospective Analysis of Statin Use and Outcome After Thoracic Cancer Surgery

30 de marzo de 2017 actualizado por: Vanderbilt University Medical Center
There is data to support an association between impaired preoperative endothelial function and adverse postoperative outcome. This study will investigate the potential association between perioperative statin use and improved perioperative and long-term cancer outcome amongst thoracic surgery patients undergoing lung or esophageal resection.

Descripción general del estudio

Descripción detallada

Statins are well established for the use of primary and secondary prevention of cardiovascular disease. Moreover, there is increasing evidence that statins have numerous effects separate from their lipid lowering properties-pleiotropic effects. These pleiotropic effects, including a reduction in the inflammatory response and improved endothelial function, may improve perioperative outcomes via modulation of the surgical stress response. Improved perioperative outcomes have been demonstrated in patients undergoing vascular, cardiac and non-cardiovascular surgery. Specific to the thoracic surgery population, statin use has been reported to reduce the incidence of atrial fibrillation.

Statins, via inhibition of the rate limiting step of the mevalonate pathway, have also sparked interest in their potential anticancer effects as well as in cancer prevention. There is some evidence for anticancer effects of statins in patients with esophageal and lung cancer. Additionally, other agents with known anti-inflammatory effects also point to the potential for improved outcome in cancer patients. In this regard, aspirin use is reported to associate with prolonged survival in breast cancer patients, while perioperative use of anti-inflammatory agents (COX-II inhibitor use and lung cancer; aprotinin use and mesothelioma; aprotinin use and esophageal cancer) is associated with improved postoperative survival. Moreover, the use of regional analgesia is commonly employed in the thoracic surgery population and has been associated with attenuation of metastasis and improvement in recurrence rates for some types of cancers.

In a prospective pilot study of patients undergoing elective thoracic surgery, a collaborative member of our group recently found that patients suffering postoperative complications had poorer endothelial function, as measured by flow mediated dilation. Those patients with poorer endothelial function had greater wound healing complications (6% vs. 0%, p=0.01), longer ICU length of stay (4 vs. 0.9 days, p=0.02), and longer hospital length of stay (14 vs. 6.9 days, p=0.01). Although this pilot study was underpowered to demonstrate a significant correlation between Brachial Artery Reactivity Testing (BART) derived endothelial function and "all" postoperative complications, it provides hypothesis generating data and supports the hypothesis that statins, as modulators of endothelial function, may have a role in improving postoperative outcome.

Tipo de estudio

De observación

Inscripción (Actual)

569

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

This study is a retrospective chart review of adult thoracic surgery patients who underwent:

  • Esophagectomy
  • Pulmonary wedge resection
  • Pulmonary lobectomy
  • Pulmonary pneumonectomy

Data collected will be from January 1, 2007 forward.

Descripción

Inclusion Criteria:

This study is a retrospective chart review of adult thoracic surgery patients who underwent:

  • Esophagectomy
  • Pulmonary wedge resection
  • Pulmonary lobectomy
  • Pulmonary pneumonectomy

Data collected will be from January 1, 2007 forward

Exclusion Criteria:

None

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Thoracic sugery statins
Thoracic surgery non-statins

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Effect of perioperative statin use on in-hospital morbidity after thoracic cancer surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Effect of perioperative statin use on the development of Major Adverse Pulmonary Events (MAPE)
Periodo de tiempo: 30 days after initial surgery
Includes acute lung injury, acute respiratory distress syndrome, pulmonary embolus, respiratory failure requiring mechanical ventilation and pneumonia
30 days after initial surgery
Effect of perioperative statin use and the development of Major Adverse Cardiac Events (MACE)
Periodo de tiempo: 30 days after initial surgery
Includes atrial fibrillation, other arrhythmia, myocardial infarction and congestive heart failure.
30 days after initial surgery
Effect of perioperative statin on mortality associated with cancer recurrence following thoracic cancer surgery.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Justin Sandall, D.O., Vanderbilt University
  • Director de estudio: Mias Pretorius, M.D., Vanderbilt University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2010

Finalización primaria (Actual)

1 de mayo de 2012

Finalización del estudio (Actual)

1 de mayo de 2012

Fechas de registro del estudio

Enviado por primera vez

14 de julio de 2010

Primero enviado que cumplió con los criterios de control de calidad

22 de julio de 2010

Publicado por primera vez (Estimar)

23 de julio de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de abril de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

30 de marzo de 2017

Última verificación

1 de marzo de 2017

Más información

Términos relacionados con este estudio

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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