Interest of CPET to Predict Mortality and Complications of Lung Resection Candidates

NCT05502263 | Unknown

• 1 other identifier: 2021293
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise Test; Thoracic Cancer

Outcome Measures

Primary Outcomes (4)

• Mortality

  death

  within 30 days after surgery

• Mortality

  death

  within 12 months after surgery

• Major respiratory complication in hospital

  pneumonia (chest roentgenogram infiltrates/consolidation, leukocytosis, fever) * respiratory failure needng mechanical ventilation for longer than 48 hours, adult respiratory distress syndrome

  within 30 days after surgery

• Minor respiratory complication in hospital

  air leak \>5 day (Patient experienced a postoperative air leak for \>5 days),atelectasis requiring bronchoscopy, atrial or ventricular arrhythmia, Empyema, Wound infection, delirium, renal failure

  within 30 days after surgery

Study Arms (2)

moderate/high risk

FEV and/or DLCO \<80% And VO2peak \<20ml/kg.min or \<75% predicted value

Control

FEV and DLCO \>80% and VO2peak \> 20ml/kg.min or \>75% predicted value

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Lobectomy or Segmentectomy or Wedge Resection for a patient Non-Small Cell Lung cancer patient

You may qualify if:

• \- Performed CPET

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Libre de Bruxelles: lead

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

RECRUITING

Related Publications (1)

• Brunelli A, Belardinelli R, Pompili C, Xiume F, Refai M, Salati M, Sabbatini A. Minute ventilation-to-carbon dioxide output (VE/VCO2) slope is the strongest predictor of respiratory complications and death after pulmonary resection. Ann Thorac Surg. 2012 Jun;93(6):1802-6. doi: 10.1016/j.athoracsur.2012.03.022. Epub 2012 May 4.

  PMID: 22560968 BACKGROUND

Study Officials

• Kevin Forton, PhD

  Erasme University Hospital ULB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis Gillet, Pt, Msc

CONTACT

+3225558386; alexis.gillet@erasme.ulb.ac.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 16, 2022
• Study Start: May 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 30, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

BE (1)