NCT01169051

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
569

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

July 14, 2010

Last Update Submit

March 30, 2017

Conditions

EsophagectomyPulmonary Wedge ResectionPulmonary LobectomyPulmonary Pneumonectomy

Keywords

EsophagectomyPulmonary wedge resectionPulmonary lobectomyPulmonary pneumonectomyThoracic SurgeryLung CancerEsophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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)

    30 days after initial surgery

  • Effect of perioperative statin use and the development of Major Adverse Cardiac Events (MACE)

    30 days after initial surgery

  • Effect of perioperative statin on mortality associated with cancer recurrence following thoracic cancer surgery.

Study Arms (2)

Thoracic sugery statins

Thoracic surgery non-statins

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Justin Sandall, D.O.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

  • Mias Pretorius, M.D.

    Vanderbilt University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 23, 2010

Study Start

July 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

April 4, 2017

Record last verified: 2017-03