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Trial Title:
Interest of CPET to Predict Mortality and Complications of Lung Resection Candidates
NCT ID:
NCT05502263
Condition:
Exercise Test
Thoracic Cancer
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Summary:
Anatomic lung resection is the treatment of choice for the management of cancerous lung
nodules Non-Small-Cell Lung Carcinoma (NSCLC). Systematic functional evaluation can
reduce the risk of mortality and morbidity of candidates. Scientific societies recommend
a cardiac and spirometry evaluation (including pulmonary diffusion capacity). In this
context, patients with FEV1 or less than 80% of the predicted value are subjected to a
more thorough evaluation of the physical physical capacity by cardiopulmonary exercise
test (CPET) to determine VO2 max (Brunelli et al 2009). Patients with a VO2 max <35% of
predicted values or <10ml/kg/min, or a postoperative predicted value of DLCO or
FEV1(ppoDLCO, ppoVEMS) less than 30% associated with a postoperative VO2max less than 35%
or 10 ml/min/kg should be offered an alternative treatment option (Begum et al 2016). In
contrast, a VO2max greater than 20ml/min/kg is considered at low surgical risk (Brunelli
et al 2009).
For patients with a VO2 max between 10 and 20ml/kg/min, operability depends on the extent
of the resection. In this group of patients, other parameters measured with CPET could be
used to optimize the selection of patients given the inability of some the inability of
some patients to provide a maximal effort, thus resulting in a sub-maximal evaluation of
physical capacity.
The VE/VCO2 slope, ventilatory equivalents or chronotropic recovery are parameters
classically used in classically used in heart failure and have recently been shown to be
independent prognostic factors as independent prognostic factors for 90-day and 2-year
mortality after anatomical lung resection. Moreover, these factors do not depend on the
maximality of the test and could again help us to risk-stratify for a sub-maximal and
therefore not optimal test.
Criteria for eligibility:
Study pop:
Lobectomy or Segmentectomy or Wedge Resection for a patient Non-Small Cell Lung cancer
patient
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria: Lobectomy or Segmentectomy or Wedge Resection for Non-Small Cell Lung
cancer
- Performed CPET
Exclusion Criteria:
- pulmonary resection for diagnostic
- pneumonectomies and any extensive resections (chest wall-associated resections,
Pancoast tumors, resection of the atrium or superior vena cava, resection of the
diaphragm, spinal resection, pleuro-pneumonectomy, tracheal sleeve pneumonectomy,
intrapericardial pneumonectomy), as well as metastases, benign lesions, and any
other non-oncologic pulmonary resections
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Erasme Hospital
Address:
City:
Brussels
Zip:
1070
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Alexis Gillet, Msc
Phone:
025558386
Email:
alexis.gillet@erasme.ulb.ac.be
Contact backup:
Last name:
Forton Kevin, PhD
Phone:
025555016
Email:
kevin.forton@ulb.be
Start date:
May 1, 2022
Completion date:
October 30, 2022
Lead sponsor:
Agency:
Université Libre de Bruxelles
Agency class:
Other
Source:
Université Libre de Bruxelles
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05502263
