RECRUITING

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

Conditions

Emphysema or COPD COPD Chronic Obstructive Lung Disease Chronic Obstructive Pulmonary Disease Emphysema Video-assisted thoracic surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-05-24

Study Completion:2024-05-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05257681

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.

Ages Eligible for Study:40 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-24

Study Completion Date2024-05-24

Study Record Updates

Study Start Date2022-05-24

Study Completion Date2024-05-24

Terms related to this study

Keywords Provided by Researchers

COPD
Chronic Obstructive Lung Disease
Chronic Obstructive Pulmonary Disease
Emphysema
Video-assisted thoracic surgery

Additional Relevant MeSH Terms

Emphysema or COPD