DIVision of the Interlobar Fissure in Patients Who Do Not Respond to Endobronchial Lung Volume Reduction

Starting soon · Not applicable

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD), Emphysema, Lung Volume Reduction Surgery

In brief

Surgical division of fissure is hypothesized to be safe and feasible. However, there is no preparatory study to test this hypothesis. It is logically expected that morbidity from the procedure could be less than standard LVRS and in preparation to a side-to-side trial of fissure division versus standard LVRS, a safety and feasibility study is required to test this hypothesis and inform future trial design.

Key facts

Study ID

NCT07682168

Run by

Rocco Bilancia

People needed

15

Starts

2026-08-01

Expected to finish

2028-01-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age < or equal 75 years
• Stable COPD with less than or equal to 10mg prednisolone daily
• Nonsmoking for 3 months prior to screening and willing to not smoke during the study duration
• Willing and able to complete protocol required study follow-up assessments and procedures
• Fit for thoracoscopy under general anaesthesia (surgical and anaesthetic assessment)
• Recent (< 18 months) endobronchial lung volume reduction (EBLVR) and lack of response defined by:
• Persistent symptomatic dyspnoea (mMRC >2) which in the patient's view is no better than baseline
• Absence of target lobar collapse with any residual aeration apparent on imaging
• Persistence of (6a) and (6b) following post procedure StratX CT analysis and revisional bronchoscopy.

You may not qualify if…

• Fissure completeness <90% on pre EBLVR StratX (i.e less than 10% of fissure to be divided)
• Chartis positive for collateral ventilation or not performed/not satisfactory at initial EBLVR
• Quantitative perfusion of target lobe >25% of total on SPECT assessment.
• Previous lung surgery or pleurodesis on the target side for LVR.
• Clinically significant bronchiectasis -greater than 4 tablespoons mucus per day.
• More than 3 COPD exacerbation episodes in the last year.
• Evidence of hypercapnia (pCO2 >7KPa) - ABG to be performed on admission for index procedure
• Clear evidence of pulmonary hypertension (systolic pulmonary arterial pressure >45mmHg) or evidence or right ventricular dysfunction as determined by a recent echocardiogram (<12mo)
• Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (<12mo)
• Myocardial infarction within 6 months of screening.
• Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.

Full record on ClinicalTrials.gov

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