Clinical trial NCT01169051: A Retrospective Analysis of Statin Use and Outcome After Thoracic Cancer Surgery
Official title: A Retrospective Analysis of Statin Use and Outcome After Thoracic Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagectomy
Pulmonary Wedge Resection
Pulmonary Lobectomy
Pulmonary Pneumonectomy
Keywords: Esophagectomy
Pulmonary wedge resection
Pulmonary lobectomy
Pulmonary pneumonectomy
Thoracic Surgery
Lung Cancer
Esophageal Cancer
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 569
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of perioperative statin use on in-hospital morbidity after thoracic cancer surgery
Secondary outcomes:
measure: Effect of perioperative statin use on the development of Major Adverse Pulmonary Events (MAPE)
timeFrame: 30 days after initial surgery
measure: Effect of perioperative statin use and the development of Major Adverse Cardiac Events (MACE)
timeFrame: 30 days after initial surgery
measure: Effect of perioperative statin on mortality associated with cancer recurrence following thoracic cancer surgery.
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Justin Sandall, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Mias Pretorius, M.D.
role: STUDY_DIRECTOR
References: