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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Lobectomy; Esophagectomy; Pulmonary Wedge Resection; Pulmonary Pneumonectomy

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.

• Study Type: Observational
• Enrollment (Actual): 569

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Thoracic sugery statins
Thoracic surgery non-statins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effect of perioperative statin use on in-hospital morbidity after thoracic cancer surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of perioperative statin use on the development of Major Adverse Pulmonary Events (MAPE)	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)	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.

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Justin Sandall, D.O., Vanderbilt University; Study Director: Mias Pretorius, M.D., Vanderbilt University

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: July 14, 2010
• First Submitted That Met QC Criteria: July 22, 2010
• First Posted (Estimated): July 23, 2010

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Lung Cancer; Esophageal Cancer; Thoracic Surgery; Esophagectomy; Pulmonary lobectomy; Pulmonary wedge resection; Pulmonary pneumonectomy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Head and Neck Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Esophageal Diseases; Lung Neoplasms; Esophageal Neoplasms
• Other Study ID Numbers: 100698