BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

Prospective, 2-arm, randomised (2:1), multicentre, open-label clinical trial in patients with severe emphysema. The intervention arm will be treated with Bronchoscopic lung volume reduction in severe emphysema using thermoablation.The interventional treatment (bronchoscopic lung volume reduction) is compared with the usual conservative standard therapy (GOLD guidelines).

Inclusion Criteria:Written informed consent obtained from the patientSevere emphysema with indication for BTVA:bilateral heterogeneous emphysema of the upper lobes in GOLD stage 3/4.evidence of severe emphysema in high-resolution computed tomographyfunctional evidence of severe pulmonary hyperinflationCollateral ventilation positiveFEV1 post lysis between 20% and < 45% (calculated)Total lung capacity (TLC) ≥ 100% (calculated)Residual volume (RV) > 175% (calculated)arterial blood gas values of: PaCO2 ≤ 50 mmHg; PaO2 > 50 mmHg on room air.marked dyspnoea with a score ≥ 2 on the Medical Research Council modified scale (mMRC).6-minute walk test > 140 metresPatient-specific, pre-interventional exhaustion of conservative treatment optionsoptimised medical therapy (according to the GOLD guidelines)Non-smoker for 6 months prior to inclusionEvidence of completed pulmonary and geriatric rehabilitation in the last 4 years≥ 6 weeks outpatient or≥ 3 weeks inpatient orParticipation in regular physical activities that go beyond the activities of daily living (e.g. a walking programme)Mentally and physically able to participate in the study procedures and visitsIndication within the framework of an interdisciplinary case conference with specialists in pneumology, radiology and thoracic surgery in accordance with §3 of the guideline on quality assurance measures in accordance with § 136 Paragraph 1 Sentence 1 Number 2 SGB V for inpatient care with bronchoscopic lung volume reduction procedures for severe emphysema (QS-RL BLVR).Exclusion Criteria:Any condition that would interfere with the conduct of the clinical trial follow-up or bronchoscopy or affect the outcome of the clinical trialDLCO < 20% (calculated)Body mass index (BMI) < 18 kg/m2 or > 32 kg/m2Pulmonary hypertensionPeak systolic PAP > 45 mmHg or mean PAP > 25 mmHgRight heart catheter measurements are considered authoritative over echocardiogram measurementsClinically significant bronchiectasisPneumothorax or pleural effusions within the last 6 monthsHeart and/or lung transplantation, surgical lung volume reduction (LVRS), bullectomy or thoracic surgery with removal of lung tissueRecent respiratory infection or COPD exacerbation in the last 6 weeksUnstable COPD (any of the following conditions):>3 COPD-related hospitalisations requiring antibiotics in the last 12 monthsCOPD-related hospital stay in the last 3 monthsdaily use of systemic steroids, > 5 mg prednisoloneSingle large bulla (defined as > 1/3 of the volume of the lobe) in the upper lobe or paraseptal emphysema distribution in the lobe being treatedCoagulopathy or current use of anticoagulantsPatients with current endobronchial valves or explanted valves in the target lobe with obvious airway obstruction in a segment to be treated with InterVapor®Patients with implanted, endobronchial coils (coils)Patients with previous endobronchial polymer/adhesive treatmentPatients with immune system disorders or concomitant diseases that necessitate the use of immunosuppressants of clinical relevanceHistory of any of the following conditions:Myocardial infarction or acute coronary syndrome in the previous yearHospitalisation for left heart failure in the last yearclinically leading asthma disease or alpha-1-antitrypsin deficiencyKnown sensitivity to medications required to perform bronchoscopyLife expectancy < 12 monthsNewly prescribed morphine derivatives within the last 4 weeksPregnancy at the time of inclusion