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

Emphysema or COPD Clinical Trial

Official title:

Comparison of Lung Volume Reduction Surgery Versus Bronchoscopic Lung Volume Reduction in Patients With Homogenous Emphysema: A Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04781582
• Other study ID #: 20-9518-BO
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: November 2024

Study information

• Verified date: September 2021
• Source: Universität Duisburg-Essen
• Contact: Clemens Aigner, Prof. MD
• Phone: +49201433
• Email: clemens.aigner[@]rlk.uk-essen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: November 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Emphysema
• Emphysema or COPD
• Pulmonary Emphysema

Intervention

Procedure:
• Lung volume reduction surgery
Surgical lung volume reduction
• Bronchoscopic lung volume reduction
Bronchoscopic lung volume reduction by endobronchial valves

Locations

Country	Name	City	State
Germany	University Medicine Essen	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FEV1 compared to baseline (deltaFEV1)	Percent change in FEV1	6 months post intervention
Secondary	Change in BODE Index (Body mass index, airflow obstruction, dyspnoea and exercise capacity in chronic obstructive pulmonary disease)	Combined score including BMI, FEV1, 6 MWT, MRC dyspnoea score; range 0 (best) - 10 (worst)	3, 6 months post intervention
Secondary	Change in TLC	Percent change in Total Lung Capacity	3, 6 months post intervention
Secondary	Change in RV	Percent change in Residual Volume	3, 6 months post intervention
Secondary	Change in RV/TLC	Percent change in RV/TLC ratio	3, 6 months post intervention
Secondary	Change in DLCO	Percent change in diffusion capacity	3, 6 months post intervention
Secondary	Change in systolic pulmonary artery pressure	measured by echocardiography	6 months post intervention
Secondary	Changes in health-related quality of life measured by SGRQ	St. George´s Respiratory Questionnaire (score 0-100, higher scores indicating more limitations)	3, 6 months post intervention
Secondary	Changes in respiratory health status measured by CAT	COPD Assessment Test (CAT)	3, 6 months post intervention
Secondary	Mortality	Number of deaths 30 days post intervention	30 days post intervention
Secondary	Overall survival	Percent of patients alive 6 months post intervention	6 months post intervention
Secondary	Incidence of (serious) adverse events	Number of events periprocedural, 1, 3 and 6 months post intervention	Periprocedural, 1, 3, 6 months post intervention