Clinical trial NCT05717192: BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Official title: Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emphysema or Chronic Obstructive Pulmonary Disease
Lead sponsor: IHF GmbH - Institut für Herzinfarktforschung
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 224
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: Currently, there is less data on the use of bronchoscopic thermoablation (BTVA) for the treatment of patients with emphysema. However, the current studies suggest with a high degree of certainty that bronchoscopic lung volume reduction for severe emphysema using thermoablation has the potential to be a necessary treatment alternative. The trial study should therefore contribute to proving the benefit of this procedure as an effective and safe treatment option in order to guarantee emphysema patients sufficient, appropriate and economical care, taking into account evidence-based medical knowledge.

Eligibility criteria: Inclusion Criteria:

* 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.
* evidence of severe emphysema in high-resolution computed tomography
* functional evidence of severe pulmonary hyperinflation
* Collateral ventilation positive
* FEV1 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 metres
* Patient-specific, pre-interventional exhaustion of conservative treatment options
* optimised medical therapy (according to the GOLD guidelines)
* 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
* Participation 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 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).

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 trial
* DLCO \< 20% (calculated)
* Body mass index (BMI) \< 18 kg/m2 or \> 32 kg/m2
* Pulmonary hypertension
* Peak systolic PAP \> 45 mmHg or mean PAP \> 25 mmHg
* Right heart catheter measurements are considered authoritative over echocardiogram measurements
* Clinically significant bronchiectasis
* Pneumothorax or pleural effusions within the last 6 months
* Heart and/or lung transplantation, surgical lung volume reduction (LVRS), bullectomy or thoracic surgery with removal of lung tissue
* Recent respiratory infection or COPD exacerbation in the last 6 weeks
* Unstable COPD (any of the following conditions):
* \>3 COPD-related hospitalisations requiring antibiotics in the last 12 months
* COPD-related hospital stay in the last 3 months
* daily use of systemic steroids, \> 5 mg prednisolone
* Single large bulla (defined as \> 1/3 of the volume of the lobe) in the upper lobe or paraseptal emphysema distribution in the lobe being treated
* Coagulopathy or current use of anticoagulants
* Patients 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 treatment
* Patients with immune system disorders or concomitant diseases that necessitate the use of immunosuppressants of clinical relevance
* History of any of the following conditions:
* Myocardial infarction or acute coronary syndrome in the previous year
* Hospitalisation for left heart failure in the last year
* clinically leading asthma disease or alpha-1-antitrypsin deficiency
* Known sensitivity to medications required to perform bronchoscopy
* Life expectancy \< 12 months
* Newly prescribed morphine derivatives within the last 4 weeks
* Pregnancy at the time of inclusion

Primary outcomes:
measure: Change in patient-reported disease-specific quality of life
timeFrame: 9 months
Secondary outcomes:
measure: Vital status
timeFrame: 3, 9 and 12 months
measure: Change in FEV 1
timeFrame: 3, 9 and 12 months
measure: Change in RV
timeFrame: 3, 9 and 12 months
measure: Change in patient-reported, disease-specific quality of life
timeFrame: 3, 9 and 12 months
measure: Serious Adverse Events
timeFrame: 3, 9 and 12 months
measure: 6-minute walk test (6MWT)
timeFrame: 3, 9 and 12 months
measure: Severe excacerbations
timeFrame: 3, 9 and 12 months
measure: Mortality
timeFrame: 3, 9 and 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
city: Essen
country: Germany
facility: Pneumologische Universitätsklinik Ruhrlandklinik
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Heidelberg
country: Germany
facility: Thoraxklinik University of Heidelberg
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Münnerstadt
country: Germany
facility: Thoraxzentrum Bezirk Unterfranken
city: Stralsund
country: Germany
facility: Helios Hanseklinikum Stralsund
Study officials:
References: