LVRS Versus BLVR in Patients With Homogenous Emphysema, CLUB-HE Trial
- Conditions
- Emphysema or COPD
- Interventions
- Procedure: Lung volume reduction surgeryProcedure: Bronchoscopic lung volume reduction
- Registration Number
- NCT04781582
- Lead Sponsor
- Universität Duisburg-Essen
- Brief Summary
This is a prospective randomized clinical trial comparing surgical and bronchoscopic lung volume reduction in patients with advanced homogeneous emphysema suitable for both procedures.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lung volume reduction surgery arm Lung volume reduction surgery 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. Bronchoscopic lung volume reduction arm Bronchoscopic lung volume reduction 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.
- Primary Outcome Measures
Name Time Method Change in FEV1 compared to baseline (deltaFEV1) 6 months post intervention Percent change in FEV1
- Secondary Outcome Measures
Name Time Method Change in BODE Index (Body mass index, airflow obstruction, dyspnoea and exercise capacity in chronic obstructive pulmonary disease) 3, 6 months post intervention Combined score including BMI, FEV1, 6 MWT, MRC dyspnoea score; range 0 (best) - 10 (worst)
Change in TLC 3, 6 months post intervention Percent change in Total Lung Capacity
Change in RV 3, 6 months post intervention Percent change in Residual Volume
Change in RV/TLC 3, 6 months post intervention Percent change in RV/TLC ratio
Change in DLCO 3, 6 months post intervention Percent change in diffusion capacity
Change in systolic pulmonary artery pressure 6 months post intervention measured by echocardiography
Changes in health-related quality of life measured by SGRQ 3, 6 months post intervention St. George´s Respiratory Questionnaire (score 0-100, higher scores indicating more limitations)
Changes in respiratory health status measured by CAT 3, 6 months post intervention COPD Assessment Test (CAT)
Mortality 30 days post intervention Number of deaths 30 days post intervention
Overall survival 6 months post intervention Percent of patients alive 6 months post intervention
Incidence of (serious) adverse events Periprocedural, 1, 3, 6 months post intervention Number of events periprocedural, 1, 3 and 6 months post intervention
Trial Locations
- Locations (1)
University Medicine Essen
🇩🇪Essen, NRW, Germany