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Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction (SAVED-1)

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ClinicalTrials.gov Identifier: NCT05257681
Recruitment Status : Recruiting
First Posted : February 25, 2022
Last Update Posted : June 13, 2022
Sponsor:
Information provided by (Responsible Party):
Adnan Majid, MD, Beth Israel Deaconess Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Emphysema or COPD Procedure: Interlobar fissure completion and pleural adhesiolysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study is expected to enroll a total of 20 subjects with a follow-up period of 3 months. All interventions and follow-up will be performed at the BIDMC. In current medical practice, emphysema patients that fail to achieve target lung volume reduction after endobronchial valves placement, are continued on current medical management for their COPD, with consideration for lung transplantation should they be eligible depending on clinical circumstances and degree of lung function impairment. The investigators plan to offer this patient population the possibility to undergo a VATS fissure completion and adhesiolysis.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inter-lobar Fissure Completion as a Salvage Treatment in Patients With Failed Bronchoscopic Lung Volume Reduction
Actual Study Start Date : May 24, 2022
Estimated Primary Completion Date : May 24, 2024
Estimated Study Completion Date : May 24, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Experimental: Fissure completion and adhesiolysis arm
Patients will undergo a VATS or robotic interlobar lung fissure completion with pleural adhesiolysis. After a 3 month follow-up period, patients will fill additional quality of life questionnaires including the St.George Respiratory Questionnaire, COPD Assessment tool, and the modified medical research council dyspnea scale. Pulmonary function testing and a high-resolution CT scan will be performed at the end of the 3-month postoperative follow-up.
Procedure: Interlobar fissure completion and pleural adhesiolysis
A video-assisted thoracic surgery or robotic approach will be used to perform pleural adhesiolysis and the lobar fissure adjacent to the previously targeted lobe during bronchoscopic lung volume reduction will be completed using a surgical stapler.




Primary Outcome Measures :
  1. Prove that inter-lobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction [ Time Frame: 2 years ]
    The investigators will determine that performing the surgery is feasible if the target inter-lobar fissure can be completed in at least 90% of the patients enrolled.

  2. Incidence of severe adverse events [ Time Frame: 2 years ]
    The investigators will actively monitor and record the severe adverse events that require any kind of additional intervention (medical or surgical) during and after the procedure. In case the treating physicians consider that the complications seen in patients outweigh the benefits obtained, the surgical technique will be revised and possible changes will be discussed.


Secondary Outcome Measures :
  1. Percentage of patients to achieve target lung volume reduction [ Time Frame: 2 years ]
    Describe the percentage of patients that achieve target lung volume reduction of at least 350mL at three months after the procedure.

  2. Percentage of patients with quality of life improvement [ Time Frame: 2 years ]
    Describe the changes in quality of life based on three subjective questionnaires that will be given to patients at baseline and three months after the intervention.

  3. Percentage of patients with significant changes in pulmonary function testing [ Time Frame: 2 years ]
    Describe the changes in PFTs after the intervention.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05257681


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Adnan Majid, MD FCCP    617-632-8252    amajid@bidmc.harvard.edu   
Principal Investigator: Adnan Majid, MD FCCP         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Publications:
Global Initiative for Chronic Obstructive Lung Disease (GOLD): Global Strategy for the Diagnosis, Management, and Prevention of COPD 2022.

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Responsible Party: Adnan Majid, MD, Chief Interventional Pulmonology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05257681    
Other Study ID Numbers: 2022P000048
First Posted: February 25, 2022    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adnan Majid, MD, Beth Israel Deaconess Medical Center:
COPD
Chronic Obstructive Lung Disease
Chronic Obstructive Pulmonary Disease
Emphysema
Video-assisted thoracic surgery
Additional relevant MeSH terms:
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Pulmonary Emphysema
Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases