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).
• Age: ≥ 40 years and ≤ 75 years
• Written informed consent obtained from the patient
• Severe emphysema with indication for BTVA:
• bilateral heterogeneous emphysema of the upper lobes in GOLD stage 3/4 and
• evidence of severe emphysema in high-resolution computed tomography (not older than 6 months prior to inclusion) and
• functional evidence of severe pulmonary hyperinflation and
• FEV1 post lysis between 20% and \< 45% (calculated) and
• Total lung capacity (TLC) ≥ 100% (calculated) and
• Residual volume (RV) \> 175% (calculated) and
• arterial blood gas values of: PaCO2 ≤ 50 mmHg; PaO2 \> 50 mmHg on room air and
• marked dyspnoea with a score ≥ 2 on the Medical Research Council modified scale (mMRC) and
• 6-minute walk test \> 140 metres
• Patient-specific, pre-interventional exhaustion of conservative treatment options
• optimised medical therapy (according to the GOLD guidelines) and
• Non-smoker for 6 months prior to inclusion
• Evidence of completed pulmonary and geriatric rehabilitation in the last 4 years
• ≥ 6 weeks outpatient or
• ≥ 3 weeks inpatient or
• Individual Participation in regular physical activities that go beyond the activities of daily living (e.g. a walking programme)
• According to the investigator's assessment mentally and physically able to participate in the study procedures and visits
• Indication 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).