LVRS Versus BLVR in Patients With Homogenous Emphysema, CLUB-HE Trial

Universität Duisburg-Essen

Status: Enrolling

Conditions: Emphysema or COPD

Treatments: Procedure: Lung volume reduction surgery; Procedure: Bronchoscopic lung volume reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT04781582

20-9518-BO

Details and patient eligibility

About

This is a prospective randomized clinical trial comparing surgical and bronchoscopic lung volume reduction in patients with advanced homogeneous emphysema suitable for both procedures.

Full description

Lung volume reduction surgery (LVRS) as well as bronchoscopic lung volume reduction (BLVR) provide functional improvements in selected patients with homogenous emphysema and pronounced hyperinflation. A direct comparison of LVRS and BLVR in patients with homogenous emphysema is not available, thus the study will provide important data to guide treatment selection in this patient population.

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COPD III-IV
• Age ≥ 18 years
• FEV1 < 50% predicted after bronchodilatation
• Significant hyperinflation (TLC >100% predicted, RV > 200% predicted, RV/TLC > 60%)
• Non-smoker or ex-smoker for > 3 months (documented by cotinine testing)
• 6 MWT >150 m and ≤ 450m
• MRC dyspnea score > 3
• Homogenous emphysema as assessed by HR-CT (< 15% difference in emphysema destruction score between target lobe and ipsilateral lobe) [16, 17]
• Uni- or bilateral collateral ventilation (CV) negative result assessed fissure completeness>95% in QCT and confirmed by a bronchoscopic procedure (Chartis©)
• Optimal medical therapy for > 3months, sufficient rehabilitation status with no need for further training/rehabilitation or rehabilitation within 6 months prior to intervention.
• Body Mass Index (BMI) > 18, but < 35 kg/m2
• Daily dose of prednisone ≤ 10mg

Exclusion criteria

• Contraindication against either LVRS or BLVR and/or to surgery and bronchoscopy in general
• Major comorbidities limiting survival
• Age ≥ 80 years
• Nicotine abuse within 3 months (documented by cotinine testing)
• Predominance of either left or right lung of >70% in perfusion SPECT scintigraphy
• FEV1 and/or DLCO <20% predicted (post bronchodilatation)
• Untreated Hypoxemia (PaO2 < 50 mmHg)
• Untreated Hypercapnia (PaCO2 > 50 mmHg)
• Significant pulmonary fibrosis or bronchiectasis
• Destroyed/vanished lung on HR-CT
• Previous chest surgery or bronchoscopic interventions
• Pulmonary hypertension (sPAP > 35 mmHg)
• Active waiting list for lung transplantation
• Patient is not able to understand and willing to sign a written informed consent document.
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Lung volume reduction surgery arm

Active Comparator group

Description:

Bilateral videothoracoscopic lung volume reduction surgery by wedge resection. Unilateral procedures are possible in case of severe adhesions or intraoperative instability. In these cases a staged approach with contralateral LVRS within 3 months is possible.

Treatment:

Procedure: Lung volume reduction surgery

Bronchoscopic lung volume reduction arm

Active Comparator group

Description:

Primarily unilateral bronchoscopic lung volume reduction by endobronchial valves. If a bilateral procedure is feasible it must be performed within 3 months after the first intervention.

Treatment:

Procedure: Bronchoscopic lung volume reduction