Inter-lobar Fissure Completion as a Salvage Treatment in Patients With Failed Bronchoscopic Lung Volume Reduction
Beth Israel Deaconess Medical Center
Summary
The purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the potential role of lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema/COPD patients with failed bronchoscopic lung volume reduction (BLVR) via the use of endobronchial valves (EBVs) therapy. In select patients, the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery (VATS) guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal and determine whether this experimental strategy will improve outcomes after failed BLVR in patients with severe emphysema/COPD.
Description
The investigators will approach all patients with failed EBV therapy. Patients with less than 350 ml of volume reduction in the target lobe and persistent dyspnea \[score greater or equal to 2 on the Modified Medical Research Council Dyspnea Scale (mMRC)\] after EBV placement will be considered to have failed EBV therapy due to adhesions or collateral ventilation being present. Only patients with failed EBV therapy will be approached to participate in our study. Once the patient agrees to participate and sign the consent, all the screening information collected as part of the standard of care…
Eligibility
- Age range
- 40–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Current pneumococcus vaccination. * Current influenza vaccination. * Target lung volume reduction \<350ml after bronchoscopic lung volume reduction (BLVR). * Persistent dyspnea defined as an mMRC score greater or equal to 2 after bronchoscopic lung volume reduction (BLVR). * Endobronchial valves (EBV) are still in place. * Willing and able to complete protocol required study follow-up assessm…
Interventions
- ProcedureInterlobar fissure completion and pleural adhesiolysis
A video-assisted thoracic surgery or robotic approach will be used to perform pleural adhesiolysis and the lobar fissure adjacent to the previously targeted lobe during bronchoscopic lung volume reduction will be completed using a surgical stapler.
Location
- Beth Israel Deaconess Medical CenterBoston, Massachusetts