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

NCT05257681 | Recruiting DMC

• 1 other identifier: 2022P000048
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Emphysema or COPD

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Prove that inter-lobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction

  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 years

• Incidence of severe adverse events

  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.

  2 years

Secondary Outcomes (3)

• Percentage of patients to achieve target lung volume reduction

  2 years

• Percentage of patients with quality of life improvement

  2 years

• Percentage of patients with significant changes in pulmonary function testing

  2 years

Study Arms (1)

Fissure completion and adhesiolysis arm

EXPERIMENTAL

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

Interventions

Interlobar fissure completion and pleural adhesiolysis PROCEDURE

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.

Fissure completion and adhesiolysis arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

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MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Interventional Pulmonology

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 25, 2022
• Study Start: May 24, 2022
• Primary Completion (Estimated): May 24, 2026
• Study Completion (Estimated): May 24, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)