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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01169051
First received: July 14, 2010
Last updated: July 22, 2010
Last verified: July 2010
  Purpose

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.


Condition
Esophagectomy
Pulmonary Wedge Resection
Pulmonary Lobectomy
Pulmonary Pneumonectomy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Retrospective Analysis of Statin Use and Outcome After Thoracic Cancer Surgery

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Effect of perioperative statin use on in-hospital morbidity after thoracic cancer surgery [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of perioperative statin use on the development of Major Adverse Pulmonary Events (MAPE) [ Time Frame: 30 days after initial surgery ] [ Designated as safety issue: Yes ]
    Includes acute lung injury, acute respiratory distress syndrome, pulmonary embolus, respiratory failure requiring mechanical ventilation and pneumonia

  • Effect of perioperative statin use and the development of Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days after initial surgery ] [ Designated as safety issue: Yes ]
    Includes atrial fibrillation, other arrhythmia, myocardial infarction and congestive heart failure.

  • Effect of perioperative statin on mortality associated with cancer recurrence following thoracic cancer surgery. [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: July 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Thoracic sugery statins
Thoracic surgery non-statins

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169051

Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Justin Sandall, D.O. Vanderbilt University
Study Director: Mias Pretorius, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Justin Sandall, D.O., Vanderbilt University
ClinicalTrials.gov Identifier: NCT01169051     History of Changes
Other Study ID Numbers: 100698
Study First Received: July 14, 2010
Last Updated: July 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Esophagectomy
Pulmonary wedge resection
Pulmonary lobectomy
Pulmonary pneumonectomy
Thoracic Surgery
Lung Cancer
Esophageal Cancer

ClinicalTrials.gov processed this record on July 26, 2014