None listed
Conditions
Brief summary
AIM: To evaluate the safety and efficacy of VATS fissure completion (closing of air passage between lobes of the lung) followed by insertion of Zephyr Valves on improving the clinical status of participants with severe Chronic Obstructive Pulmonary Disease who have collateral ventilation (air moving between lobes). PARTICIPANTS: 20 participants at SVHM and SVPH over 24 months. METHOD: Participants will undergo two surgical procedures. The first procedure will be VATS fissure completion followed by CT assessment to ensure successful fissure completion. If successful, participants will undergo a second procedure 4 weeks later for insertion of the Zephyr Valve. Participants will be followed up over a 6 month period. EXPECTED OUTCOMES: Assessment of absolute change from pre-operative baseline at 6 months for: a. Residual Volume (RV) b. Forced Vital Capacity (FVC) c. FEV1/FVC ratio d. Total Lung Capacity (TLC) e. Exercise capacity by Six-minute walk test f. Quality of life (SGRQ) g. Dyspnoea score Percent mean change from pre-operative baseline at 6 months h. Forced Expiratory Volume in 1 second (FEV1)
Interventions
This study is investigating two separate surgeries to be used in conjunction with each other, in a subset of patients with chronic obstructive pulmonary disease (COPD). The surgical technique involved is video assisted thorascopic surgery (VATS). In this study, VATS will be used as an initial surgical procedure, to close air leaks between lung compartments (fissure completion) of participants with COPD. After this procedure, participants will undergo a second surgery, which will involve implanti
This study is investigating two separate surgeries to be used in conjunction with each other, in a subset of patients with chronic obstructive pulmonary disease (COPD). The surgical technique involved is video assisted thorascopic surgery (VATS). In this study, VATS will be used as an initial surgical procedure, to close air leaks between lung compartments (fissure completion) of participants with COPD. After this procedure, participants will undergo a second surgery, which will involve implanting a Zephyr Valve, into the most diseased part of the lung to stop inhaled air from getting to that part of the lung. The Zephyr Valve is currently approved for use in COPD patients that do not have air leaks between the lung compartments, however it has not previously been used in patients requiring fissure closure. This study will be examining whether it is safe and effective to undergo VATS fissure completion and then 4 weeks later, undergo the Zephyr Valve insertion. Thoracic Surgeons will be performing both procedures. The duration of the VATS procedure will be approximately 2 hours and the duration of the Zephyr Valve insertion will be approximately 1 - 1.5 hours.
Sponsors
Pulmonx Australia Pty. Ltd.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is willing and able to provide informed consent and to participate in the study. 2. Subject is greater than or equal to 40 years of age. 3. Subject has a diagnosis of severe or very severe homogenous or heterogeneous COPD (GOLD classification1). 4. Subject has a post bronchodilator FEV1 of greater than or equal to 15% and less than or equal to 50%. 5. Subject has TLC > 100% predicted. 6. Subject has RV > 175% predicted. 7. Subject has a normal dobutamine stress echocardiogram. 8. Subject has sufficient exercise tolerance i.e. 6MWT is greater than or equal to 150m and less than or equal to 450m. 9. Subject has an incomplete lobar fissure i.e. < 90%, as confirmed by CT evaluation of lung fissures. 10. Collateral ventilation confirmed as assessed by Chartis Assessment (to be confirmed during first procedure/operation) 11. Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhaemoglobin or cotinine levels. 12. Subject is up to date with preventive vaccinations including seasonal influenza vaccine and pneumococcal vaccine consistent with the Victorian Department of Health and Human Services Immunisation Schedule Guidelines (updated March 2018).
Exclusion criteria
1. Subject has a history of previous thoracotomy, lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any form. 2. Subject has an acute COPD exacerbation. 3. Subject has evidence of active respiratory infection. 4. Subject has a post bronchodilator FEV1 < 15%. 5. Subject has a DLCO < 20%. 6. Subject has a history of recurrent clinically significant respiratory infections, defined as three (3) or more COPD exacerbations requiring hospitalisation during the 12 months prior to study enrolment (ICF signature page). 7. Subject has severe gas exchange abnormalities as defined by any one of the following: a. PaO2 < 60 mmHg b. PaCO2 > 45 mmHg on room air c. SpO2 < 90% on less than or equal to 4 L/min supplemental O2 at rest 8. Subject use of systemic steroids > 20mg/day or equivalent and/or immunosuppressive agents in the 4 weeks prior to procedure. 9. Subject unable to temporarily interrupt use of heparins or oral anticoagulants or antiplatelet agents, excluding aspirin. 10. Subject’s pre-operative CT scan indicates the presence of any of the following radiological abnormalities: a. Pulmonary nodule is greater than or equal to 0.8 cm in diameter (does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET). b. Radiological picture consistent with active pulmonary infection, e.g. unexplained parenchymal infiltrate. c. Giant bullae > 30% of the volume of either lung. d. Significant interstitial lung disease. e. Significant pleural disease. 11. Subject’s baseline ECG demonstrates clinically significant arrhythmias or conduction abnormalities. 12. Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis. 13. Subject has a known diagnosis of alpha-1 antitrypsin deficiency. 14. Subject is classified as having “likely” pulmonary hypertension defined as tricuspid regurgitation velocity > 3.4m/s and/or pulmonary artery peak systolic pressure > 45 mmHg on echocardiogram or a previous formal diagnosis of pulmonary hypertension on right heart catheterization. 15. Subject has suspected significant coronary artery disease defined as regional wall motion abnormalities on dobutamine stress echocardiogram. 16. Subject is classified as being at major cardiac risk with the presence of unstable coronary syndromes (i.e. unstable or severe angina or recent myocardial infarct), decompensated heart failure, significant arrhythmias or severe valvular disease, which warrants intensive management of the condition in accordance with current guidelines on perioperative cardiovascular risk.
Outcome results
None listed