Back to resultsLVRS Versus BLVR in Patients With Homogenous Emphysema, CLUB-HE Trial
Primary Purpose
Emphysema or COPD
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Lung volume reduction surgery
Bronchoscopic lung volume reduction
Sponsored by
About this trial
This is an interventional treatment trial for Emphysema or COPD
Eligibility Criteria
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
Sites / Locations
- University Medicine EssenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lung volume reduction surgery arm
Bronchoscopic lung volume reduction arm
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change in FEV1 compared to baseline (deltaFEV1)
Percent change in FEV1
Secondary Outcome Measures
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)
Change in TLC
Percent change in Total Lung Capacity
Change in RV
Percent change in Residual Volume
Change in RV/TLC
Percent change in RV/TLC ratio
Change in DLCO
Percent change in diffusion capacity
Change in systolic pulmonary artery pressure
measured by echocardiography
Changes in health-related quality of life measured by SGRQ
St. George´s Respiratory Questionnaire (score 0-100, higher scores indicating more limitations)
Changes in respiratory health status measured by CAT
COPD Assessment Test (CAT)
Mortality
Number of deaths 30 days post intervention
Overall survival
Percent of patients alive 6 months post intervention
Incidence of (serious) adverse events
Number of events periprocedural, 1, 3 and 6 months post intervention
Full Information
NCT ID
NCT04781582
First Posted
February 25, 2021
Last Updated
September 27, 2021
Sponsor
Universität Duisburg-Essen
1. Study Identification
Unique Protocol Identification Number
NCT04781582
Brief Title
LVRS Versus BLVR in Patients With Homogenous Emphysema, CLUB-HE Trial
Official Title
Comparison of Lung Volume Reduction Surgery Versus Bronchoscopic Lung Volume Reduction in Patients With Homogenous Emphysema: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema or COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single center, 1:1 randomized, open label, controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lung volume reduction surgery arm
Arm Type
Active Comparator
Arm 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.
Arm Title
Bronchoscopic lung volume reduction arm
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Lung volume reduction surgery
Intervention Description
Surgical lung volume reduction
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopic lung volume reduction
Intervention Description
Bronchoscopic lung volume reduction by endobronchial valves
Primary Outcome Measure Information:
Title
Change in FEV1 compared to baseline (deltaFEV1)
Description
Percent change in FEV1
Time Frame
6 months post intervention
Secondary Outcome Measure Information:
Title
Change in BODE Index (Body mass index, airflow obstruction, dyspnoea and exercise capacity in chronic obstructive pulmonary disease)
Description
Combined score including BMI, FEV1, 6 MWT, MRC dyspnoea score; range 0 (best) - 10 (worst)
Time Frame
3, 6 months post intervention
Title
Change in TLC
Description
Percent change in Total Lung Capacity
Time Frame
3, 6 months post intervention
Title
Change in RV
Description
Percent change in Residual Volume
Time Frame
3, 6 months post intervention
Title
Change in RV/TLC
Description
Percent change in RV/TLC ratio
Time Frame
3, 6 months post intervention
Title
Change in DLCO
Description
Percent change in diffusion capacity
Time Frame
3, 6 months post intervention
Title
Change in systolic pulmonary artery pressure
Description
measured by echocardiography
Time Frame
6 months post intervention
Title
Changes in health-related quality of life measured by SGRQ
Description
St. George´s Respiratory Questionnaire (score 0-100, higher scores indicating more limitations)
Time Frame
3, 6 months post intervention
Title
Changes in respiratory health status measured by CAT
Description
COPD Assessment Test (CAT)
Time Frame
3, 6 months post intervention
Title
Mortality
Description
Number of deaths 30 days post intervention
Time Frame
30 days post intervention
Title
Overall survival
Description
Percent of patients alive 6 months post intervention
Time Frame
6 months post intervention
Title
Incidence of (serious) adverse events
Description
Number of events periprocedural, 1, 3 and 6 months post intervention
Time Frame
Periprocedural, 1, 3, 6 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clemens Aigner, Prof. MD
Phone
+49201433
Ext
4011
Email
clemens.aigner@rlk.uk-essen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Kaid Darwiche, Prof. MD
Phone
+49201433
Ext
4222
Email
kaid.darwiche@rlk.uk-essen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemens Aigner, Prof. MD
Organizational Affiliation
Universität Duisburg-Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medicine Essen
City
Essen
State/Province
NRW
ZIP/Postal Code
45239
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clemens Aigner, Prof. MD
Phone
+49201433
Ext
4011
Email
clemens.aigner@rlk.uk-essen.de
First Name & Middle Initial & Last Name & Degree
Kaid Darwiche, Prof. MD
Phone
+49201433
Ext
4222
Email
kaid.darwiche@rlk.uk-essen.de
12. IPD Sharing Statement
Plan to Share IPD
No
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LVRS Versus BLVR in Patients With Homogenous Emphysema, CLUB-HE Trial
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