EsophagectomyNCT01169051
A Retrospective Analysis of Statin Use and Outcome After Thoracic Cancer Surgery
An observational study of Esophagectomy and Pulmonary Wedge Resection, run by Vanderbilt University Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagectomy, Pulmonary Wedge Resection, Pulmonary Lobectomy
- How many people
- 569 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
About this study
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.
Read the 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.
- Keywords
- Esophagectomy, Pulmonary wedge resection, Pulmonary lobectomy, Pulmonary pneumonectomy, Thoracic Surgery, Lung Cancer, Esophageal Cancer
- Medical subject headings
- Lung Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic sugery statins | Not described | |
| Thoracic surgery non-statins | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of perioperative statin use on in-hospital morbidity after thoracic cancer surgery
Secondary outcomes (3)
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
Measured: 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.
Measured: 30 days after initial surgery
Effect of perioperative statin on mortality associated with cancer recurrence following thoracic cancer surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagectomyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Sandall, D.O., Principal investigator, Vanderbilt UniversityMias Pretorius, M.D., Study director, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169051
- Sponsor's protocol ID
- 100698
- Status last verified
- May 2026
- First submitted
- 14 Jul 2010
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Statin Use and Outcome After Thoracic Cancer Surgery
- ClinicalTrials.gov ID
- NCT01169051
- Acronym / sponsor ID
- 100698
- Keywords
- Esophagectomy, Pulmonary wedge resection, Pulmonary lobectomy, Pulmonary pneumonectomy, Thoracic Surgery, Lung Cancer, Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic sugery statins | – | – |
| Thoracic surgery non-statins | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- This study is a retrospective chart review of adult thoracic surgery patients who underwent:
- Esophagectomy
- Pulmonary wedge resection
- Pulmonary lobectomy
- Pulmonary pneumonectomy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of perioperative statin use on in-hospital morbidity after thoracic cancer surgery
3 secondary outcomes
Effect of perioperative statin use on the development of Major Adverse Pulmonary Events (MAPE)
Time frame: 30 days after initial surgery
Effect of perioperative statin use and the development of Major Adverse Cardiac Events (MACE)
Time frame: 30 days after initial surgery
Effect of perioperative statin on mortality associated with cancer recurrence following thoracic cancer surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Sandall, D.O. principal investigator
Vanderbilt University
Mias Pretorius, M.D. study director
Vanderbilt University
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagectomy and Pulmonary Wedge Resection, run by Vanderbilt University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of perioperative statin use on in-hospital morbidity after thoracic cancer surgery. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.