Fissure Completion Surgery for COPD
(SAVED-1 Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be able to safely stop anticoagulants or platelet activity inhibitors for 7 days.
What data supports the effectiveness of the treatment Interlobar fissure completion and pleural adhesiolysis for COPD?
Is Fissure Completion Surgery for COPD safe for humans?
How does the treatment 'Interlobar fissure completion and pleural adhesiolysis' for COPD differ from other treatments?
This treatment is unique because it involves completing the interlobar fissures (the natural separations between lung lobes) and removing pleural adhesions (scar tissue in the chest cavity), which can help improve lung function by reducing air leaks and enhancing lung volume reduction. Unlike other COPD treatments that may focus on medication or non-surgical interventions, this approach directly addresses structural issues in the lungs.1241112
Eligibility Criteria
This trial is for people aged 40-75 with severe emphysema/COPD who didn't improve after a specific lung procedure (BLVR). Participants must be stable on low-dose steroids, vaccinated against pneumococcus and influenza, non-smokers for at least 4 months, and still have breathlessness. They should also have the valves from their previous treatment in place.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo VATS or robotic interlobar lung fissure completion with pleural adhesiolysis
Postoperative Management
Participants are monitored for air leaks and other complications, with potential valve adjustments
Follow-up
Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and pulmonary function testing
Treatment Details
Interventions
- Interlobar fissure completion and pleural adhesiolysis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor