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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04781582
Other study ID # 20-9518-BO
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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 (ChartisĀ©) - 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


Related Conditions & MeSH terms


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. GeorgeĀ“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
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