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

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

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

Study Overview

• Status: Recruiting
• Conditions: Emphysema or COPD
• Intervention / Treatment: Procedure: Lung volume reduction surgery; Procedure: Bronchoscopic lung volume reduction

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 Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clemens Aigner, Prof. MD; Phone Number: 4011 +49201433; Email: clemens.aigner@rlk.uk-essen.de
• Study Contact Backup: Name: Kaid Darwiche, Prof. MD; Phone Number: 4222 +49201433; Email: kaid.darwiche@rlk.uk-essen.de

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45239
      • Recruiting
      • University Medicine Essen
      • Contact: Clemens Aigner, Prof. MD; Phone Number: 4011 +49201433; Email: clemens.aigner@rlk.uk-essen.de
      • Contact: Kaid Darwiche, Prof. MD; Phone Number: 4222 +49201433; Email: kaid.darwiche@rlk.uk-essen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lung volume reduction surgery arm; 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.	Procedure: Lung volume reduction surgery; Surgical lung volume reduction
Active Comparator: Bronchoscopic lung volume reduction arm; 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.	Procedure: Bronchoscopic lung volume reduction; Bronchoscopic lung volume reduction by endobronchial valves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FEV1 compared to baseline (deltaFEV1)	Percent change in FEV1	6 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in TLC	Percent change in Total Lung Capacity	3, 6 months post intervention
Change in RV	Percent change in Residual Volume	3, 6 months post intervention
Change in RV/TLC	Percent change in RV/TLC ratio	3, 6 months post intervention
Change in DLCO	Percent change in diffusion capacity	3, 6 months post intervention
Change in systolic pulmonary artery pressure	measured by echocardiography	6 months post intervention
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
Changes in respiratory health status measured by CAT	COPD Assessment Test (CAT)	3, 6 months post intervention
Mortality	Number of deaths 30 days post intervention	30 days post intervention
Overall survival	Percent of patients alive 6 months post intervention	6 months post intervention
Incidence of (serious) adverse events	Number of events periprocedural, 1, 3 and 6 months post intervention	Periprocedural, 1, 3, 6 months post intervention

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Principal Investigator: Clemens Aigner, Prof. MD, Universität Duisburg-Essen

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 20-9518-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No