Fissure Completion Surgery for COPD
(SAVED-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new surgical method to help people with severe emphysema or COPD breathe easier. It focuses on those who have already tried endobronchial valves (tiny devices placed in the lungs to help reduce their size) but did not experience sufficient relief. The surgery, called interlobar fissure completion and pleural adhesiolysis, involves completing lung fissures and removing adhesions (scar tissue) to improve lung function. Suitable candidates have severe COPD, still have the valves in place, and experience frequent shortness of breath. As an unphased trial, this study offers patients a unique opportunity to explore a novel surgical approach that could significantly improve their quality of life.
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 prior data suggests that this protocol is safe for severe emphysema/COPD patients?
Research shows that specific safety information for fissure completion and pleural adhesiolysis in patients with severe emphysema or COPD is not available. However, similar procedures using video-assisted thoracic surgery (VATS) have been performed in other contexts. These procedures are generally considered safe, though risks such as infection or bleeding can occur, as with any surgery.
In other studies involving lung treatments, patients typically tolerated the procedures well, with few serious side effects. Since this trial is in its early stages, detailed safety information may not yet be available. However, the procedures tested have been used in other settings, suggesting they might be safe. It is important to discuss potential risks and benefits with healthcare providers.12345Why are researchers excited about this trial?
Unlike the standard COPD treatments such as bronchodilators, steroids, or oxygen therapy, which primarily aim to manage symptoms, the fissure completion surgery targets the physical structure of the lungs. This surgical approach involves completing the interlobar fissures and performing pleural adhesiolysis, which can potentially improve lung function by enhancing ventilation and reducing trapped air. Researchers are excited about this technique because it directly addresses structural issues within the lungs, offering the potential for improved breathing and quality of life in ways that current medical therapies do not.
What evidence suggests that this protocol is effective for severe emphysema/COPD?
Research suggests that interlobar fissure completion and pleural adhesiolysis might benefit patients with severe emphysema or COPD who haven't found success with bronchoscopic lung volume reduction (BLVR). This trial evaluates the effectiveness of this procedure, which aims to improve lung function by reducing air leaks between lung lobes. Studies have shown that video-assisted thoracoscopic surgery, a less invasive type of surgery, for fissure completion can enhance breathing and quality of life. The procedure involves stapling the lung fissures and removing scar tissue, potentially leading to better outcomes. While more research is needed, early findings indicate this approach could be promising for those who haven’t benefited from other treatments.12346
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Interlobar fissure completion and pleural adhesiolysis
Trial Overview
The study tests if performing a surgical technique called fissure completion with pleural adhesiolysis can help patients whose lungs didn't shrink enough after BLVR. This involves using video-assisted surgery to seal parts of the lung and remove scar tissue to potentially improve breathing.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients will undergo a VATS or robotic interlobar lung fissure completion with pleural adhesiolysis. After a 3 month follow-up period, patients will fill additional quality of life questionnaires including the St.George Respiratory Questionnaire, COPD Assessment tool, and the modified medical research council dyspnea scale. Pulmonary function testing and a high-resolution CT scan will be performed at the end of the 3-month postoperative follow-up.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Citations
Inter-lobar Fissure Completion in Patients With Failed ...
The purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the potential role of lung fissure completion with ...
Fissure Completion Surgery for COPD (SAVED-1 Trial)
What data supports the effectiveness of the treatment Interlobar fissure completion and pleural adhesiolysis for COPD? Research shows that completing interlobar ...
Outcome and safety 90 days after combined airway valve ...
Our data suggest that combined RUL and ML valve implantation appears to be a promising interventional treatment strategy in patients with severe heterogenous ...
Combined Zephyr Valve System With Inter-lobar Fissure ...
COPD patients with severe emphysema and incomplete lobar fissures will undergo video-assisted thoracic surgery fissure completion and valves placement. After a ...
Presence of pleural adhesions can predict conversion to ...
The conversion and postoperative morbidity rates were 3.2% and 29.2%, respectively. There were 154 patients with pleural adhesions (Group A) and 439 patients ...
Effects of degree of pulmonary fissure completeness on ...
To evaluate the clinical significance of degree of pulmonary fissure completeness (PFC) on major in-hospital outcomes following video-assisted ...
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