The purpose of this protocol is to perform a pilot prospective randomized controlled clinical trial to evaluate the potential role of lung fissure completion strategy (experimental intervention) in addition to endobronchial valve (EBV) placement (representing "standard-of-care") in select patients with severe COPD/emphysema and with evidence for \<95% fissure completion between adjacent lung lobes. In select patients, lung fissure completion strategy will be performed by either video-assisted thorascopic surgery (VATS)-guided or robotic-guided stapling along the lung fissures in an attempt to reduce collateral ventilation and determine whether or not this experimental strategy will improve outcome following subsequent EBV placement. EBV placement will follow successful VATS-guided or robotic-guided fissure stapling.
The study will enroll approximately 20 patients at BIDMC, and outcomes will focus on procedure-related complications, physiological measurements (ex., FEV1 by pulmonary function testing) and clinical symptoms (i.e., questionnaires). Patient will be followed for 3-month period, receiving usual standard of care during the 3 months of follow-up. The goal of this protocol is to determine if elimination of significant collateral lung ventilation between lung lobes is possible, and whether such strategy to eliminate collateral lung ventilation between lobes improves outcomes following subsequent EBV placement (i.e. promotes atelectasis of diseased lung segments) in the management of severe COPD/emphysema in appropriate candidates. For subjects in the medical management control group, upon completion of the 3-month F/U period, they will be eligible for EBV if they choose.
Age 40 to 75 years.
Stable with less than 10mg prednisone (or equivalent) daily.
Nonsmoking for 4 months prior to screening and willing to not smoke during the study duration.
Completed a supervised pulmonary rehabilitation program less than equal to 12 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 12 months prior.
> 95% fissure completion on high-resolution chest CT-scan (HRCT) or StratX evaluation with a Chartis evaluation negative for collateral ventilation.
Clinically significant (greater than 4 tablespoons per day) mucus production.
Myocardial infarction within 6 months of screening.
Uncontrolled congestive heart failure.
Crossover
Robotic or VATS lobar fissure completion
Procedure/SurgeryThe lobar fissure adjacent to the target lobe will be completed using a surgical stapler through robotic or video-assisted thoracic surgery.
Endobronchial valves placement
DeviceEndobronchial valves will be placed in the target lobe after the fissure completion.
Prove that inter-lobar fissures can be completed to at least 95% via robotic thoracic surgery or VATS in severe emphysema patients
We will determine that we met this feasibility objective if the target inter-lobar fissure can be completed in at least 90% of the patients undergoing surgery.
Prove that patients consented for the procedure will ultimately undergo the intervention
We will determine that the study is feasible if at least 90% of consented patients in the intervention arm undergo the procedure.
Incidence of severe adverse events
We will actively monitor and record the severe adverse events that require any kind of additional intervention (medical or surgical) during and after the combined procedure. In case the treating physicians consider that the complications seen in patients outweigh the benefits obtained, the surgical technique will be revised and possible changes will be discussed.
Percentage of patients to achieve target lung volume reduction
Describe the percentage of patients that achieve target lung volume reduction of at least 350mL at three months after the combined procedure.
Percentage of patients with quality of life improvement
Describe the changes in quality of life based on three subjective questionnaires that will be given to patients at baseline and three months after any intervention.
Percentage of patients with significant changes in pulmonary function testing
Describe the changes in PFTs after the intervention.
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Beth Israel Deaconess Medical Center
Lead sponsor
Pulmonx Corporation
Collaborator
