Pilot Trial of Combined Surgical Fissure Completion and Zephyr Valve Placement for Lung Volume Reduction in Severe Emphysema and COPD

What this Trial Is About

Researchers are conducting a pilot randomized controlled trial to study a new lung fissure completion strategy combined with endobronchial valve EBV placement in patients with severe COPD or emphysema who have incomplete lung fissures less than 95% completion. The goal is to see if completing the lung fissures surgically can reduce collateral ventilation between lung lobes and improve outcomes after EBV placement. The study will enroll about 20 patients and focus on complications, lung function tests, and symptom questionnaires over a 3-month follow-up. Participants will be randomly assigned to either receive the experimental intervention, which includes robotic or video-assisted thoracic surgery VATS to complete the lung fissure followed by EBV placement, or to a medical management group receiving usual care. The surgical procedure involves stapling the incomplete fissures under general anesthesia, followed by assessment of collateral ventilation and valve placement during the same or a closely timed procedure. Patients in the medical management group may choose to cross over to the intervention after 3 months. During the study, participants will undergo bronchoscopy, pulmonary function tests, quality of life questionnaires Saint George Respiratory Questionnaire, COPD Assessment Test, and dyspnea assessment modified Medical Research Council scale. Follow-up visits at 14 days and 3 months will collect clinical data, CT scans, and lung function results. Safety and adverse events will be monitored throughout, with a total participation period of about 3 months plus possible crossover treatment.

Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema