20 Participants Needed

Fissure Completion Surgery for COPD

(SAVED-1 Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that completing interlobar fissures can improve lung volume reduction in patients with emphysema, a condition similar to COPD. This suggests that the treatment might help improve breathing and lung function in COPD patients by addressing incomplete fissures.12345

Is Fissure Completion Surgery for COPD safe for humans?

The research articles do not provide specific safety data for Fissure Completion Surgery for COPD, but they do discuss related procedures like autologous blood patch pleurodesis and bronchopleural fistula management, which have been used safely in patients with lung conditions.678910

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

You still have endobronchial valves in your lungs.
I am taking less than 10mg of prednisone or its equivalent daily.
I am between 40 and 75 years old.
See 6 more

Exclusion Criteria

I have had pneumonia 3 or more times in the past year.
I have had 3 or more flare-ups of my COPD in the past year.
I cough up more than 4 tablespoons of mucus daily.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants undergo VATS or robotic interlobar lung fissure completion with pleural adhesiolysis

1 week
1 visit (in-person)

Postoperative Management

Participants are monitored for air leaks and other complications, with potential valve adjustments

1-2 weeks
Ongoing monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and pulmonary function testing

3 months
2 visits (in-person)

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Fissure completion and adhesiolysis armExperimental Treatment1 Intervention
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

Trials
872
Recruited
12,930,000+

References

Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. [2016]
Robot-assisted thoracoscopic lobectomy for severe incomplete interlober fissure. [2021]
Combined Thoracoscopic Surgical Stapling and Endobronchial Valve Placement For Lung Volume Reduction With Incomplete Lobar Fissures: An Experimental Pilot Animal Study. [2021]
Fissureless technique of robotic left lingular segmentectomy for primary lung cancer with incomplete fissure: a case report. [2023]
The Prediction of Fissure Integrity by Quantitative Computed Tomography Analysis. [2023]
Intrapleural instillation of autologous blood for persistent air leak in spontaneous pneumothorax in patients with advanced chronic obstructive pulmonary disease. [2016]
Endoscopic management of large, postresection bronchopleural fistulae with methacrylate adhesive (Super Glue). [2019]
Dataset of a study investigating autologous blood patch pleurodesis in postoperative prolonged air leaks after lung resection. [2020]
Detecting the limits of bronchial closure methods in an animal model. [2006]
Acellular dermal matrix closure of catastrophic bronchopleural fistula. [2010]
Fissure-last technique for left upper lobe lung cancer with interlobar invasion: how to do it? [2022]
A simple technique to avoid postoperative air leakages after right upper lobectomy. [2013]