Clinical trial NCT04781582: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Emphysema or COPD
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single center, 1:1 randomized, open label, controlled
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in FEV1 compared to baseline (deltaFEV1)
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Change in BODE Index (Body mass index, airflow obstruction, dyspnoea and exercise capacity in chronic obstructive pulmonary disease)
timeFrame: 3, 6 months post intervention
measure: Change in TLC
timeFrame: 3, 6 months post intervention
measure: Change in RV
timeFrame: 3, 6 months post intervention
measure: Change in RV/TLC
timeFrame: 3, 6 months post intervention
measure: Change in DLCO
timeFrame: 3, 6 months post intervention
measure: Change in systolic pulmonary artery pressure
timeFrame: 6 months post intervention
measure: Changes in health-related quality of life measured by SGRQ
timeFrame: 3, 6 months post intervention
measure: Changes in respiratory health status measured by CAT
timeFrame: 3, 6 months post intervention
measure: Mortality
timeFrame: 30 days post intervention
measure: Overall survival
timeFrame: 6 months post intervention
measure: Incidence of (serious) adverse events
timeFrame: Periprocedural, 1, 3, 6 months post intervention
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Medicine Essen
state: NRW
Study officials:
affiliation: Universität Duisburg-Essen
name: Clemens Aigner, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: