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Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema

ConditionEmphysema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorIsabelle Opitz, Professor, MD

About this trial

The investigators plan to perform a randomized controlled trial that compares bilateral lung volume reduction surgery (LVRS) with bronchoscopic lung volume reduction (BLVR) using endobronchial valves in terms of efficacy and patient safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients suffering from emphysema (all morphologies, uni- or bilateral distribution) potentially qualifying for both study procedures, LVRS or BLVR (if possible, perfusion scintigraphy within < 6 month of screening, CT scan within < 4 months of screening)

Age ≥ 30 and ≤ 80 years

Body Mass Index (BMI) ≥ 16, but ≤ 35 kg/m2

Non-smoking for 3 months prior to screening interview

Disqualifiers

FEV1 more than 50% predicted

TLC less than 100 % predicted, RV less than 175% predicted, RV/TLC less than 58% predicted, and DLCO ≤ 20% predicted in homogeneous emphysema and DLCO ≤ 15% in heterogeneous emphysema, respectively

PaO2 ≤ 6.0 kPa (45mm Hg) at ambient air (only applicable for homogeneous morphology!)

PaCO2 ≥ 6.6 kPa (50 mmHg) at ambient air (only applicable for homogeneous morphology!)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lung volume reduction surgery

    Procedure/Surgery

    Lung volume reduction by surgery

  • Bronchoscopic lung volume reduction with valves

    Procedure/Surgery

    Lung volume reduction with endobronchial valves.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: LVRS treatment groupExperimental treatment 1 intervention
Group B: BLVR study groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline value in FEV1 (ml)

Percent change in FEV1

Time frame
6 months after intervention

Secondary outcomes

1

Change from baseline value in FEV1

Percent change in forced expiratory volume (FEV1)

Time frame
3 and 12 months after intervention
2

Change from baseline value in RV

Percent change in residual volume (RV)

Time frame
3, 6 and 12 months after intervention
3

Change from baseline value in TLC

Percent change in total lung capacity (TLC)

Time frame
3, 6 and 12 months after intervention
4

Change from baseline value in RV/TLC

Percent change in RV-to-TLC ratio

Time frame
3, 6 and 12 months after intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Isabelle Opitz, Professor, MD

Lead sponsor

University of Zurich

Sponsor institution

Source ClinicalTrials.gov
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