Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction

Description

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.

Conditions

Emphysema or COPD

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Study Overview

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Study Details

Study overview

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.

Inter-lobar Fissure Completion as a Salvage Treatment in Patients With Failed Bronchoscopic Lung Volume Reduction

Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction

Condition
Emphysema or COPD
Intervention / Treatment

-

Contacts and Locations

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

40 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Beth Israel Deaconess Medical Center,

Study Record Dates

2024-05-24