Lung surgery for patients with severe emphysema who didn't improve with bronchoscopic treatment
Inter-lobar Fissure Completion as a Salvage Treatment in Patients With Failed Bronchoscopic Lung Volume Reduction
This study is testing a new lung surgery for people with severe emphysema who didn't get better from other treatments to see if it can help them breathe easier and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05257681 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial evaluates the effectiveness of a surgical procedure called lung fissure completion with pleural adhesiolysis in patients suffering from severe emphysema or COPD who have not benefited from bronchoscopic lung volume reduction using endobronchial valves. The study aims to determine if this experimental approach can improve lung function and quality of life by reducing collateral ventilation and removing adhesions. Patients will be assessed for eligibility based on their previous treatment outcomes and will undergo various health evaluations before and after the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 75 with severe emphysema or COPD who have experienced inadequate improvement after bronchoscopic lung volume reduction.
Not a fit: Patients with significant mucus production, recent heart issues, or those who have undergone certain lung surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve lung function and quality of life for patients with severe emphysema or COPD who have not responded to previous treatments.
How similar studies have performed: While this specific approach is novel, similar surgical interventions have shown promise in improving outcomes for patients with severe lung conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.