Ventilation-Perfusion Discrepancy Index Versus Conventional Anatomic-Physiologic Assessment for Target Lung Lobe Selection in Endobronchial Valve Placement: A Multicenter, Randomised Controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

VQDI-assisted target lung lobe selection strategy: Participants in this arm undergo endobronchial valve (EBV) placement in a target lobe selected specifically based on functional imaging. Among all lobes confirmed to have no collateral ventilation (assessed by the Chartis system), the lobe with the lowest Ventilation-Perfusion Discrepancy Index (VQDI) - indicating the most severe mismatch between air flow and blood flow - is chosen for treatment. All other procedural aspects, screening assessments, and follow-up are identical to the comparator arm.

Conventional target lung lobe selection strategy: Participants in this arm undergo endobronchial valve (EBV) placement in a target lobe selected based on standard anatomical criteria. Among all lobes confirmed to have no collateral ventilation (assessed by the Chartis system), the lobe with the highest CT destruction score - indicating the most severe anatomical emphysema - is chosen for treatment. This reflects current standard-of-care practice. All other procedural aspects, screening assessments, and follow-up are identical to the experimental arm.

Study summary

The goal of this clinical trial is to learn if a Ventilation-Perfusion Discrepancy Index (VQDI)-guided strategy for selecting the target lung lobe can improve outcomes compared to the standard strategy in patients with severe emphysema undergoing bronchoscopic lung volume reduction with endobronchial valves (EBVs).

The main question it aims to answer is:

· Does selecting the target lobe based on the lowest VQDI (indicating the worst functional mismatch) lead to a higher rate of successful treatment response at 6 months compared to selecting the lobe based on the worst destruction on CT scan?

If there is a comparison group: Researchers will compare the VQDI-guided selection group to the conventional CT/Chartis-guided selection group to see which strategy results in more patients achieving significant improvement in both lung function and reduction in the size of the treated lobe.

Participants will:

* Undergo standard clinical assessments (lung function tests, CT scan, exercise test) and an additional V/Q SPECT/CT scan to calculate the VQDI.
* Have their collateral ventilation status checked using the Chartis system during bronchoscopy.
* Be randomly assigned to one of the two target lobe selection strategies.
* Receive EBV placement in the selected lobe.
* Attend follow-up visits at 1, 3, 6, and 12 months after the procedure for check-ups, repeated lung function tests, questionnaires, and CT scans to assess their response to treatment.

Eligibility

Primary outcome measure(s)

• Ventilation-Perfusion Discrepancy Index (VQDI) — 6 month
  The absolute change in the target lobe's VQDI from baseline to 6 months post-procedure.

Trial sites (1)

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