Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction
Recruiting · NCT05257681 · Interventional (participants receive a specific treatment) · Lead sponsor: Beth Israel Deaconess Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 assessments and procedures.
Exclusion criteria
- Clinically significant (greater than 4 tablespoons per day) mucus production.
- Myocardial infarction within 6 months of screening.
- Decompensated heart failure.
- Three or more pneumonia episodes in last year.
- Three or more COPD exacerbation episodes in the last year.
- Prior lung transplant, LVRS, bullectomy, or lobectomy.
- Clinically significant bronchiectasis.
- Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.
- Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \>45mmHg) or evidence or history of CorPulmonale as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).
- Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).
- Resting bradycardia (\<50 bpm), Complex ventricular arrhythmia, sustained SVT.
- PaCO2 greater than 50mmHg on room air at screening.
- PaO2 less than 45mmHg on room air at screening.
Where it is running
1 location listed across 1 US state.
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States