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

27. maj 2026 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

569

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Thoracic sugery statins
Thoracic surgery non-statins

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effect of perioperative statin use on the development of Major Adverse Pulmonary Events (MAPE)
Tidsramme: 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)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Justin Sandall, D.O., Vanderbilt University
  • Studieleder: Mias Pretorius, M.D., Vanderbilt University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2010

Primær færdiggørelse (Faktiske)

1. maj 2012

Studieafslutning (Faktiske)

1. maj 2012

Datoer for studieregistrering

Først indsendt

14. juli 2010

Først indsendt, der opfyldte QC-kriterier

22. juli 2010

Først opslået (Anslået)

23. juli 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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