Lung surgery for patients with severe emphysema who didn't improve with bronchoscopic treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.