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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Time Frame
Start Date: 2022-05-24
Estimated Completion Date: 2026-05-24
Participants
Target number of participants: 20
Treatments
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.
Sponsors
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov