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

Not Applicable

Recruiting

• Conditions: Emphysema or COPD

• 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.

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Study Start: 2021-06-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28
• Primary Completion: 2024-05
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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