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Not yet recruitingNCT07403617Updated Feb 11, 2026

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

An interventional study of VQDI-assisted target lung lobe selection strategy and Conventional target lung lobe selection strategy in Emphysema, sponsored by China-Japan Friendship Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
285
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.
02

Conditions studied

  • Emphysema

Keywords

  • Endobronchial Lung Volume Reduction
  • Ventilation-Perfusion Discrepancy Index
  • Emphysema
  • Chronic Obstructive Pulmonary Disease
03

In context

Emphysema

382 studies on the registry are indexed under Emphysema; 59 are open to participants now.

This study's planned enrollment of 285 is above the median of 60 across 245 interventional studies indexed under Emphysema.

Browse Emphysema studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 178 studies on the registry; 111 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical and radiological evidence of emphysema
  • Nonsmoking for 4 months prior to screening interview
  • less than 35 kg/m2
  • Stable on current medication regimen
  • (FEV1) between 15% and 45% of predicted value
  • Residual Volume less than 175% predicted (determined by body plethysmography)
  • Little or no collateral ventilation (CV-) as determined using the Chartis System

Exclusion criteria

Exclusion Criteria:

  • Had two or more hospitalizations over the last year for a exacerbation
  • Had two or more hospitalizations over the last year for pneumonia
  • Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
  • Had a heart attack or congestive heart failure within the last 6 months
  • Have heart arrhythmia
  • Is alpha-1 antitrypsin deficient
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
285 participants (estimated)

Study arms

  • Experimental
    VQDI-assisted target lung lobe selection strategy

    Target lobe selection is based on the lobe with the lowest VQDI among all lobes with an absence of collateral ventilation (Chartis-negative), indicating the most severe ventilation-perfusion mismatch.

    Procedure: VQDI-assisted target lung lobe selection strategy

  • Placebo comparator
    Conventional target lung lobe selection strategy

    Target lobe selection is based on the lobe with the highest CT destruction score among all lobes with an absence of collateral ventilation (Chartis-negative), indicating the most severe anatomical destruction.

    Procedure: Conventional target lung lobe selection strategy

Interventions

  • ProcedureVQDI-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.

  • ProcedureConventional 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.

06

What researchers measure

Primary outcomes

  1. Ventilation-Perfusion Discrepancy Index (VQDI)

    The absolute change in the target lobe's VQDI from baseline to 6 months post-procedure.

    Time frame: 6 month

Secondary outcomes

  1. St. George's Respiratory Questionnaire (SGRQ)

    Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline). The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.

    Time frame: 1 year

  2. FEV1 Post-bronchodilator Absolute Change

    Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).

    Time frame: 1 year

  3. 6-minute Walk Distance

    Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline).

    Time frame: 1 year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Oct 2028, 30 months later.

Of 40 non-industry interventional studies with no phase under Emphysema, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 58. This study's planned 30 months is below that.

Counting every sponsor, half of 60 studies reached it within 37 months; a quarter within 22 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2026
First posted
Feb 11, 2026
StartEst.
Apr 2026
Primary completionEst.
Oct 2028
CompletionEst.
Oct 2028
Last update
Feb 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07403617
Responsible party
Gang Hou (Principal Investigator, China-Japan Friendship Hospital) — Principal investigator
First posted
Feb 11, 2026
Start date
Apr 2026 (estimated)
Primary completion
Oct 2028 (estimated)
Completion
Oct 2028 (estimated)
Last update
Feb 11, 2026

Study contacts

Mingming Deng, Ph.D., M.D.
Contact
isdeng1017@163.com
+86 188-0133-6854

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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