Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema
NCT ID: NCT04537182
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
120 participants
INTERVENTIONAL
2020-09-01
2028-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Improvement of Cardiovascular Function After Bronchoscopic Lung Volume Reduction Using Endobronchial Valves
NCT04556942
Bronchioscopic Lung Volume Reduction (BLVR)
NCT02415478
Lung Volume Reductions Surgery (LVRS) Study
NCT00018525
The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients
NCT01869205
Mechanisms of Vascular Damage in Patients With Chronic Obstructive Pulmonary Disease
NCT01020344
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LVRS treatment group
A bilateral lung volume reduction surgery (LVRS) by video-assisted thoracoscopic surgery (VATS) is performed under general anesthesia with double lumen endobronchial intubation. Unilateral treatment is accepted in cases with severe adhesions or intraoperative instability making a bilateral procedure unsafe.
Lung volume reduction surgery
Lung volume reduction by surgery
BLVR study group
Unilateral bronchoscopic lung volume reduction with endobronchial valves (EBV) is performed using a flexible bronchoscope under general anesthesia and under full attendance of an anesthesiologist. Valves are placed unilaterally in segmental or subsegmental bronchi in the target lobe with the goal of complete atelectasis.
Bronchoscopic lung volume reduction with valves
Lung volume reduction with endobronchial valves.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lung volume reduction surgery
Lung volume reduction by surgery
Bronchoscopic lung volume reduction with valves
Lung volume reduction with endobronchial valves.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 30 and ≤ 80 years
* Body Mass Index (BMI) ≥ 16, but ≤ 35 kg/m2
* Non-smoking for 3 months prior to screening interview
* Patient is able to understand and willing to sign a written informed consent document.
Exclusion Criteria
* TLC less than 100 % predicted, RV less than 175% predicted, RV/TLC less than 58% predicted, and DLCO ≤ 20% predicted in homogeneous emphysema and DLCO ≤ 15% in heterogeneous emphysema, respectively
* PaO2 ≤ 6.0 kPa (45mm Hg) at ambient air (only applicable for homogeneous morphology!)
* PaCO2 ≥ 6.6 kPa (50 mmHg) at ambient air (only applicable for homogeneous morphology!)
* Patients with incomplete interlobar fissures as revealed by quantitative computed tomography analysis with StratX® (fissure completeness ≤ 80%)
* Patients with collateral ventilation as evidenced by bronchoscopic Chartis® measurement (only performed if fissure completeness according to StratX® is \< 95%)
* 6-minute walking distance ≥ 470m
* More than two COPD exacerbation episodes requiring hospitalization in the last year
* More than two instances of pneumonia episodes in the last year
* Unplanned weight loss ≥ 10% within 90 days prior to enrollment
* Pulmonary hypertension as evidenced by Delta Psyst RV-RA \> 35 mmHg on recent echocardiography (within 3 months prior to screening) and confirmed by RHC (mPAP ≥ 35 mmHg) and signs of moderate to severe RV dysfunction.
* Evidence of left ventricular ejection fraction (LVEF) less than 45% on recent echocardiography (within 3 months prior to screening)
* History of exercise-related syncope
* Myocardial infarction or congestive heart failure within 6 months of screening
* Clinically significant arrhythmias that might put the patient at risk in regard to the interventions
* Prior LVR (any method), bullectomy, or lobectomy
* Clinically significant bronchiectasis with expectoration of ≥ 2 tablespoons/day.
* Pulmonary nodule requiring surgery
* Unable to safely discontinue anticoagulants or dual antiplatelet therapy for 7 days
* Patients with a life expectancy of less than one year
30 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Isabelle Opitz, Professor, MD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Isabelle Opitz, Professor, MD
Prof. MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Isabelle Opitz, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitätsklinik für Thoraxchirurgie, Medical University of Vienna
Vienna, , Austria
University Hospital Leuven
Leuven, , Belgium
Rigshospitalet, University of Copenhagen
Copenhagen, , Denmark
Kantonsspital Aarau
Aarau, Canton of Aargau, Switzerland
Lausanne University Hospital (CHUV)
Lausanne, Canton of Vaud, Switzerland
University Hospital Zurich, Division of Thoracic Surgery
Zurich, Canton of Zurich, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SINCERE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.